| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00842000100751 | 11.1 | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio V11.1 | ||
| 2 | 00842000100980 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access 8.1 | ||
| 3 | 00842000100027 | 9.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 4 | 00842000100010 | 10.0.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 5 | 00842000100133 | 1.0 | Standalone software application. A universal workflow (non-medical tool) on Merg Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform. | LLZ | System, Image Processing, Radiological | 2 | iConnect Enterprise Workflow with Merge PACS | |
| 6 | 00842000100126 | 6.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 7 | 00842000100966 | 10.4 | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | ||
| 8 | 00842000100683 | 6.5 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | iConnect Access | |
| 9 | 00842000100645 | 6.4 | Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. | LLZ | System, Image Processing, Radiological | 2 | Merge iConnect Access | |
| 10 | 00842000100447 | 11.0 | Correcting entry. | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo | |
| 11 | 00842000100072 | 7.1.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 12 | 00842000100058 | 11.1.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 13 | 00842000100409 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 14 | 00842000100829 | 13.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | ||
| 15 | 00842000100805 | 8.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 16 | 00842000100331 | 11.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Unity PACS | |
| 17 | 00842000100935 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 18 | 00842000100690 | 7.3 | Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 19 | 00842000100607 | 7.1.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 20 | 00842000100560 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 21 | 00842000100508 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | |
| 22 | 00842000100478 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 23 | 00842000100461 | 11.0 | LLZ | System, Image Processing, Radiological | 2 | Merge Unity Pacs | ||
| 24 | 00842000100089 | 7.1.1 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 25 | 00842000100034 | 10.1 | DQK | Computer, Diagnostic, Programmable | 2 | Merge HEMO | ||
| 26 | 00842000100348 | 6.6.3.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 27 | 00842000100706 | 7.3 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 28 | 00842000100775 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 29 | 00842000100676 | 7.2 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 30 | 00842000100577 | 7.0.2 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | |
| 31 | 00842000100454 | 7.1.2.1 | LLZ | System, Image Processing, Radiological | 2 | Merge OrthoPACS | ||
| 32 | 00842000100737 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | Merge PACS | ||
| 33 | 00842000100614 | 8.32 | LLZ | System, Image Processing, Radiological | 2 | RadSuite | ||
| 34 | 00842000100515 | 77-00327-00 | Merge Hemo 77-00327-00 Link Assembly | DQK | Computer, Diagnostic, Programmable | 2 | Merge Hemo Link Assembly | |
| 35 | 00842000100041 | 10.3 | Standalone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 36 | 00842000100003 | 7.0 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 37 | 90842000100914 | 8.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 38 | 00842000100782 | 7.1 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 39 | 00842000100720 | 7.0 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 40 | 00842000101031 | 6.4 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 41 | 00842000101024 | 9.0 | Correcting entry. | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | |
| 42 | 00842000101017 | 8.2 | LLZ | System, Image Processing, Radiological | 2 | IBM iConnect Access | ||
| 43 | 00842000100928 | 12.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 44 | 00842000100881 | 6.3 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 45 | 00842000100638 | 6.2 | Standalone Software Application | LLZ | System, Image Processing, Radiological | 2 | CADstream | |
| 46 | 00842000100591 | 10.1 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 47 | 00842000100416 | 11.0 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | Merge Cardio | |
| 48 | 00842000100300 | 4.2.1 | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite | ||
| 49 | 00842000100065 | 2.0 | Stand alone software application. | LLZ | System, Image Processing, Radiological | 2 | Merge Z3D | |
| 50 | 00842000100867 | 4.3 | Standalone software application | LLZ | System, Image Processing, Radiological | 2 | eFilm Lite |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00190376470351 | AIX21000 | Vea - Mobile Alignment App | VEA | ALPHATEC SPINE, INC. | |
| 2 | 00066714700155 | V8 | CADI | Cadi Software | Cadi | SYNCA MARKETING INC |
| 3 | 00046838076619 | CCL650i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 4 | 00046838076602 | CCL650i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 5 | 00046838076596 | CCL258i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 6 | 00046838076589 | CCL258i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 7 | 00046838076572 | CCL258i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 8 | 00046838076565 | MS25i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 9 | 00046838076558 | MS25i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 10 | 00046838076541 | MS25i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 11 | 00046838076534 | MS35i2/AR | JVC | JVC KENWOOD CORPORATION | ||
| 12 | 00046838076527 | MS35i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 13 | 00046838076510 | MS35i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 14 | 00046838076367 | CCL358i2/F | JVC | JVC KENWOOD CORPORATION | ||
| 15 | 00046838076350 | CCL358i2/N | JVC | JVC KENWOOD CORPORATION | ||
| 16 | B940IVZBKIT0 | ImmersiveTouch4 | ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 17 | B940IMMERSIVEVIEW0 | V3.0 | The ImmersiveTouch simulators are intended as pre-operative software for simulat The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. | ImmersiveTouch | IMMERSIVETOUCH, INC. | |
| 18 | B843UNISYN6110 | 6-1-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 19 | B843UNISYN5610 | 5-6-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 20 | B843UNISYN5520 | 5-5-2-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 21 | B843UNISYN5510 | 5-5-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 22 | B843UNISYN5410 | 5-4-1-PX | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 23 | B843UNISYN531P20 | 5-3-1-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 24 | B843UNISYN431P10 | 4-3-1-P1 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 25 | B843UNISYN425P20 | 4-2-5-P2 | UniSyn is a software application for image registration and fusion display of sc UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. | UniSyn | CONVERGENT IMAGING SOLUTIONS INCORPORATED | |
| 26 | B80731 | Breast MRI SE | 3 | QuantX is a software program that is used to view and analyze patient breast images. | QuantX | QLARITY IMAGING, LLC |
| 27 | B80721 | Breast MRI Biopsy Guidance Plugin | 2 | The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assi The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures. | QuantX | QLARITY IMAGING, LLC |
| 28 | B801THINQ1130 | 1.1.3 | THINQ | CORTICOMETRICS LLC | ||
| 29 | B801THINQ1000 | 1.0.0 | THINQ | CORTICOMETRICS LLC | ||
| 30 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | Rapid | ISCHEMAVIEW, INC. |
| 31 | B7671R521 | 5.2.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 32 | B7671R520 | 5.2.0 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 33 | B7671R512 | 5.1.2 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 34 | B7671R511 | 5.1.1 | Rapid | Rapid | ISCHEMAVIEW, INC. | |
| 35 | B7671R5030 | 5.0.3 | Rapid | ISCHEMAVIEW, INC. | ||
| 36 | B761RAPID510 | 5.1 | Rapid 5.1 | Rapid | ISCHEMAVIEW, INC. | |
| 37 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 38 | B761RAPID5020 | 5.0.2 | RAPID | ISCHEMAVIEW, INC. | ||
| 39 | B761RAPID5010 | 5.0.1 | RAPID | ISCHEMAVIEW, INC. | ||
| 40 | B761RAPID500 | 5.0 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 41 | B761RAPID49101 | 4.9.1 | Rapid | Rapid | RAPID | ISCHEMAVIEW, INC. |
| 42 | B761RAPID48302 | 4.8.3 | RAPID | RAPID is a Platform for brain image analysis. | RAPID | ISCHEMAVIEW, INC. |
| 43 | B745VASCUCAPA2 | A.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 44 | B745ELUCIDVIVOA3 | A.3 | ElucidVivo | ELUCID BIOIMAGING INC. | ||
| 45 | B745A40 | A.1.2 | vascuCAP | ELUCID BIOIMAGING INC. | ||
| 46 | B725INITVV12 | 1.2 | INITVV | Visualize:Vascular is software that renders 3D images of vascular segments from Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging. | Visualize:Vascular | SALIENT IMAGING |
| 47 | B688IMAGEQUBE0 | ImageQube | ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication Sy ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports. | ImageQube | INTUITIVE IMAGING INFORMATICS, LLC | |
| 48 | B664CVM20 | CVM2 | Arterys Cardio DL | ARTERYS INC. | ||
| 49 | B664AVM30 | AVM3 | Arterys Viewer | ARTERYS INC. | ||
| 50 | B664AOM40 | AOM4 | Arterys Oncology DL | ARTERYS INC. |