| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00840682121651 | Extend | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Vscan | ||
| 2 | 00840682147071 | Air for iOS | Vscan Air for iOS | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | |
| 3 | 00840682147484 | Air CL A1 | Vscan Air CL A1 | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | |
| 4 | 00840682147101 | Air for Android | Vscan Air for Android | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | |
| 5 | 00840682115766 | P2D KE100005 | IYN,IYO,LLZ,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,System, image processing, radiological,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 6 | 00840682115759 | P6D-RS | IYO,LLZ,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, image processing, radiological, System, imaging, pulsed echo, ultrasonic,System, image processing, radiological,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 7 | 00840682115735 | 6Tc-RS | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | NA | ||
| 8 | 00840682115728 | 9T-RS | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | NA | ||
| 9 | 00840682115704 | P6D | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | NA | ||
| 10 | 00840682115681 | 6VT-D KN100110 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 11 | 00840682115650 | 6VT-D | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | NA | ||
| 12 | 00840682115636 | 9T | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | NA | ||
| 13 | 00840682115612 | P2D | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 14 | 00840682115599 | P2D-RS | ITX,IYN,LLZ,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, image processing, radiological,System, imaging, pulsed echo, ultrasonic | 2 | NA | ||
| 15 | 00840682115582 | 6Tc | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | NA | ||
| 16 | 00840682115384 | Gateway v.1.4 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vscan | ||
| 17 | 00840682107891 | Dual Probe | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vscan | ||
| 18 | 00840682107853 | v1.2 | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vscan | ||
| 19 | 00195278388483 | 9VT-D | KN100130 | 9VT-D Probe | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | NA |
| 20 | 00840682146883 | Software Only v204 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 21 | 00840682146876 | Plug-in v204 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 22 | 00840682104333 | Plug-in v201 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 23 | 00840682103961 | Software Only v201 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 24 | 00840682141703 | Software Only v203 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 25 | 00840682123518 | Plug-in v202 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 26 | 00840682123501 | Software Only v202 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 27 | 00840682121095 | Software Only v113 | LLZ | System, image processing, radiological | 2 | EchoPAC | ||
| 28 | 00195278504326 | Plug-in v206 | MD EchoPAC Plug-in v206 | QIH,LLZ | Automated Radiological Image Processing Software,System, image processing, radiological | 2 | EchoPAC | |
| 29 | 00195278504302 | Software Only v206 | MD EchoPAC Software Only v206 | QIH,LLZ | Automated Radiological Image Processing Software,System, image processing, radiological | 2 | EchoPAC | |
| 30 | 00840682146678 | E90 v204 with OLED | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 31 | 00840682146661 | E80 v204 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 32 | 00840682146982 | S70N v204 | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 33 | 00840682123365 | S60N v202CH | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 34 | 00840682123341 | S70N v202CH | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 35 | 00840682146975 | S60N v204CH | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 36 | 00840682146968 | S70N v204CH | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 37 | 00840682146920 | S60N v204 | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 38 | 00840682147064 | E v203 to v204 UPG | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 39 | 00840682146692 | E90 v204 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 40 | 00840682146685 | E95 v204 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 41 | 00840682147156 | S v203 to v204 UPG | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 42 | 00840682146654 | E95 v204 with OLED | Vivid E95 v204 with OLED | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | |
| 43 | 00840682146647 | E80 v204 with OLED | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 44 | 00840682143936 | S v202 to v203 UPG | IYN,ITX,IYO | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,S System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 45 | 00840682143189 | E v202 to v203 UPG | IYO,IYN,ITX | System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultras System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 46 | 00840682142885 | S70N v203 | ITX,IYN,IYO | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,S Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic | 2 | Vivid | ||
| 47 | 00840682142861 | S60N v203 | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid | ||
| 48 | 00840682141734 | E80 v203 with LCD | ITX,IYO,IYN | Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,Syst Transducer, ultrasonic, diagnostic,System, imaging, pulsed echo, ultrasonic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 49 | 00840682141727 | E90 v203 with LCD | IYO,ITX,IYN | System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,Syst System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | Vivid | ||
| 50 | 00840682141710 | E95 v203 with LCD | IYN,IYO,ITX | System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultras System, imaging, pulsed doppler, ultrasonic,System, imaging, pulsed echo, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Vivid |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00860001148596 | 2.0.2.8 | UltraRAD Product User Web Interface | UltraMANAGEMENT UTILITY | ULTRARAD CORPORATION | |
| 2 | 00860001148589 | 1.0.0.12 | UltraRAD Product User Web Interface | UltraMANAGEMENT UTILITY | ULTRARAD CORPORATION | |
| 3 | 00860001148572 | 3.0.2.362 | DICOM Modality Worklist | UltraBROKER | ULTRARAD CORPORATION | |
| 4 | 00860001148565 | 6.0.0.0 | DICOM Viewer | UltraWEB | ULTRARAD CORPORATION | |
| 5 | 00860001148558 | 3.0.3.2 | UltraPREFETCH automatically retrieves studies and sends to any DICOM client, on UltraPREFETCH automatically retrieves studies and sends to any DICOM client, on a rule based criteria. | UltraPREFETCH | ULTRARAD CORPORATION | |
| 6 | 00860001148541 | 1.0.0.0 | DICOM file import tool | UltraMEDIA | ULTRARAD CORPORATION | |
| 7 | 00860001148534 | 3.0.4.9 | DICOM Storage | UltraARCHIVE | ULTRARAD CORPORATION | |
| 8 | 00860001148527 | 3.0.4.9 | DICOM Router | UltraGATEWAY | ULTRARAD CORPORATION | |
| 9 | 00860001148510 | 1.0.0.2 | Allows sites a methodology to securely deliver electronic results and images to Allows sites a methodology to securely deliver electronic results and images to their referring physicians | UltraDISTRIBUTOR | ULTRARAD CORPORATION | |
| 10 | 00860001148503 | 2.0.0.0 | Clinical image viewer | UltraVISION | ULTRARAD CORPORATION | |
| 11 | 00860000606189 | Version 1.0 | BrainInsight | HYPERFINE RESEARCH, INC. | ||
| 12 | 00860000358705 | 1.0 | ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact w ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support. | ProKnow DS | PROKNOW, LLC | |
| 13 | 00860000233118 | A | VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or wit VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis. | VirtuOst VFA | O N DIAGNOSTICS LLC | |
| 14 | 00860000171212 | 2.x | SubtleMR is an image processing software that can be used for image enhancement SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI. | SubtleMR | SUBTLE MEDICAL, INC. | |
| 15 | 00860000171205 | 2.x | SubtlePET is an image processing software intended for use by radiologists and n SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI). | SubtlePET | SUBTLE MEDICAL, INC. | |
| 16 | 00860000004817 | 1.1 | RSI-MRI+ is standalone software that is used by radiologists, urologists, and ot RSI-MRI+ is standalone software that is used by radiologists, urologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ acceptsDICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optionalautomated fusion of derived image data with anatomical T2-weighted MR images. Some of the features of RSI-MRI+ include: • Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps. • Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series. • Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (AI) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Segmentation Series. • Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image. • Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software. NOTE: The RSI-MRI+ supported protocols differ from PI-RADS v2.1 in that they have lower inplane resolution for T2W images and thicker slices for the GE DW | RSI-MRI+ | CORTECHS LABS INC | |
| 17 | 00860000004800 | 1.5 | CT CoPilot is intended for use in automating post-acquisition quantitative analy CT CoPilot is intended for use in automating post-acquisition quantitative analysis of CT images of the brain for patients aged 18 or older. CT CoPilot performs automatic reformatting, labeling and quantification of segmentable structures from a set of CT images of the brain. Output of the software provides these values as numerical volumes and images which have been annotated with graphical color overlays, with each color representing a specific brain structure. When CT imaging is performed more than once on a patient, the current data is co-registered to the most recently processed prior exam of the same patient, facilitating comparison between the studies using CT CoPilot. Voxel-by-voxel subtraction maps of the pixel density change in Hounsfield Units (HU) are generated in up to 3 dimensions between the current and most recent processed prior exam of the patient. | CT CoPilot | CORTECHS LABS INC | |
| 18 | 00859873006110 | 1.0 | Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting f Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™ workflow consists of the following steps:• SPECT/CT or PET/CT DICOM data loading from the data manager GOLD or PACS• Registration of different time-points to a common reference study• Generation and integration of voxel-level time-activity curves• Voxel-level absorbed dose calculation using a Monte Carlo-method • Saving of the absorbed dose-map back to GOLD or PACS in DICOM format.Intended Use:The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel level as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application. Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes. Warning! The Voxel Dosimetry™ is only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose. | Voxel Dosimetry | HERMES MEDICAL SOLUTIONS AB | |
| 19 | 00859699006059 | 2.X | The Surgimap® software assists healthcare professionals in viewing, storing, and The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software. | Surgimap® | NEMARIS, INC | |
| 20 | 00859699006042 | 2.2.9.X | The Surgimap® software assists healthcare professionals in viewing, storing, and The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software. | Surgimap® | NEMARIS, INC | |
| 21 | 00858846007222 | CMDR.TW.1202.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 22 | 00858846007215 | CMDR.PE.1202.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 23 | 00858846007208 | CMDR.PE.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 24 | 00858846007192 | CMDR.TW.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 25 | 00858846007185 | CMDR.PE.100.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 26 | 00858846007178 | Integris | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 27 | 00858846007161 | CMDR.PE.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 28 | 00858846007154 | CMDR.TW.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 29 | 00858846007147 | CMDR.T.100.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 30 | 00858846007130 | CMDR.TW.100.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 31 | 00858846007123 | CMDR.TW.1202.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 32 | 00858846007116 | CMDR.T.1202.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 33 | 00858846007109 | CMDR.T.1202.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 34 | 00858846007093 | CMDR.TW.100.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 35 | 00858846007086 | CMDR.T.100.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 36 | 00858846007079 | CMDR.PE.1202.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 37 | 00858846007062 | CMDR.PE.100.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 38 | 00858846007055 | CMDR.T.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 39 | 00858846007048 | CMDR.T.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 40 | 00858846007031 | CMDR-2SLWT | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 41 | 00858701006018 | SQ3500 | SPY-Q™ or SPY-QCM™ | NOVADAQ TECHNOLOGIES INC | ||
| 42 | 00858012005922 | V3.4 | D70141, D70142, D70160 | "PowerLook Density Assessment 3.4 is a software application intended for use wit "PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid. | PowerLook Density Assessment V3.4 | ICAD, INC. |
| 43 | 00858012005786 | 3.5 | D4D0185 | The DynaCAD 3 software consists of the MR Analysis Server software and the viewe The DynaCAD 3 software consists of the MR Analysis Server software and the viewer workstation software.The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD Advanced PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.DynaCAD 3 software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD 3 software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies. | DynaCAD | ICAD, INC. |
| 44 | 00858012005779 | 3.5 | D75014-05, D57015-05 | The DynaLOC Breast Interventional Planning software module supports the use of M The DynaLOC Breast Interventional Planning software module supports the use of MR interventional breast coils and localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device.The accuracy of DynaLOC software depends on the resolution of the acquired dataset. If the sum of the slice thicknesses for marker and target series does not exceed 5 mm, the 3-dimensional accuracy is 5 mm. Otherwise it is equal to the sum of two slice thicknesses for marker and target series. The accuracy can be negatively affected by any of the following: • Significant patient movement after the breast is securely immobilized in the biopsy device• Significant displacement of tissue during needle penetration • Image distortion in the MR dataset. | DynaLOC Breast Interventional Planning Software | ICAD, INC. |
| 45 | 00858012005656 | V2.1 | DSC012 | PowerLook Density Assessment software application intended for use with digital PowerLook Density Assessment software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. | iReveal with PowerLook AMP | ICAD, INC. |
| 46 | 00858012005205 | V2.1 | D70124, D70141 and D70126 | PowerLook Density Assessment is a software application intended for use with dig PowerLook Density Assessment is a software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. | iReveal Breast Density Assessment | ICAD, INC. |
| 47 | 00857926006001 | 4.20.300 | R4 ACERT | HYLAND SOFTWARE, INC. | ||
| 48 | 00857560008003 | 6.4.3 | 113-00749 | CardioPACS is a software device intended to be used by medical professionals for CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms. | HealthView CardioPACS | LUMEDX CORPORATION |
| 49 | 00857198006006 | V1 | Oasis is a software product designed to operate on an office PC. The product is Oasis is a software product designed to operate on an office PC. The product is intended for use by qualified medical personnel for the assessment of diagnostic medical images.The software allows for the processing, review, and transfer of scintigraphy camera output data as well as related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations.Oasis is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools.The Oasis product is not intended to be used as a replacement for visual interpretation, nor as a diagnostic tool without the use of other clinical and laboratory information. | Oasis | SEGAMI CORPORATION | |
| 50 | 00857088008387 | ATEC Lateral Kit 3.0 | 900-3TX | The device consists of a sterile Snap that includes reflective features that fac The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. | TrackX | TRACKX TECHNOLOGY, LLC |