| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 60192156559852 | CS 1500 | 6559850 | CS1500 HAND PIECE WIRELESS | EIA | Unit, Operative Dental | 1 | CS 1500 |
| 2 | 60192156559814 | CS 1500 | 6559819 | CS1500 INTRA ORAL CAMERA WIRED USB | EIA | Unit, Operative Dental | 1 | CS 1500 |
| 3 | 60192156559807 | CS 1500 | 6559801 | CS1500 INTRA ORAL CAMERA WIRELESS | EIA | Unit, Operative Dental | 1 | CS 1500 |
| 4 | 60192155943065 | 5943063 | 5943063 | CS 3800 3D I/O SCANNER WIRELESS | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | CS 3800 Wireless |
| 5 | 60192155942723 | CS 7200 | 5942727 | CS 7200 IMAGING PLATE SYSTEM | MUH | System, X-Ray, Extraoral Source, Digital | 2 | CS 7200 |
| 6 | 60192155501548 | Trophypan Supreme 3D | 5501549 | Trophypan Supreme 3D | OAS | X-Ray, Tomography, Computed, Dental | 2 | Trophypan Supreme 3D |
| 7 | 60192155313585 | CS 8100 Access | 5313580 | CS 8100 ACCESS | MUH | System,x-ray,extraoral source,digital | 2 | CS 8100 Access |
| 8 | 60192155302886 | SINGLE USE SLEEVES - 3D BITE BLOCK | 5302880 | SINGLE USE SLEEVES - 3D BITE BLOCK | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | SINGLE USE SLEEVES - 3D BITE BLOCK |
| 9 | 60192155211010 | CEPHALOSTAT | 5211016 | CEPH UPGRADE FOR 9X00 FAMILY | MUH,OAS | System,x-ray,extraoral source,digital,X-ray, tomography, computed, dental | 2 | CEPHALOSTAT |
| 10 | 60192155944482 | 5944483 | 5944483 | LICENCE CS MODEL+ V5 ALIGNER CAPABILITY | PNN | Orthodontic Software | 2 | CS Model+ |
| 11 | 60192155943218 | 5943212 | 5943212 | CS 8200 3D | MUH,OAS | System, X-Ray, Extraoral Source, Digital,X-Ray, Tomography, Computed, Dental | 2 | CS 8200 3D |
| 12 | 60192155942716 | CS Model+ | 5942719 | CS MODEL+ | PNN | Orthodontic Software | 2 | CS Model+ |
| 13 | 60192155500329 | CS 8100 3D Access | 5500327 | CS 8100 3D ACCESS | OAS,MUH | X-ray, tomography, computed, dental,System,x-ray,extraoral source,digital | 2 | CS 8100 3D Access |
| 14 | 60192155008184 | Hygienic Sleeves 3D Bite Block | BDA16 | PROTECTIONS HYGIENIQUE MORDU 3D CSD | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | Hygienic Sleeves 3D Bite Block |
| 15 | 60192155008160 | RVG 5100 | CIC52 | CAPTEUR RVG 5100 T2 CSD | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 5100 |
| 16 | 60192155008016 | RVG 5100 | CIC39 | CAPTEUR RVG 5100 T1 CSD | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 5100 |
| 17 | 40192155942651 | CS 7600 Hygienic Sheath | 5942651 | CS 7600 HYG SHEATHS SIZE 4 200 PCS | KQM | Camera, Surgical And Accessories | CS 7600 Hygienic Sheath | |
| 18 | 40192155942644 | CS 7600 Hygienic Sheath | 5942644 | CS 7600 HYG SHEATHS SIZE 3 200 PCS | KQM | Camera, Surgical And Accessories | CS 7600 Hygienic Sheath | |
| 19 | 40192155942637 | CS 7600 Hygienic Sheath | 5942636 | CS 7600 HYG SHEATHS SIZE 2 200 PCS | KQM | Camera, Surgical And Accessories | CS 7600 Hygienic Sheath | |
| 20 | 40192155942620 | CS 7600 Hygienic Sheath | 5942628 | CS 7600 HYG SHEATHS SIZE 1 200 PCS | KQM | Camera, Surgical And Accessories | CS 7600 Hygienic Sheath | |
| 21 | 40192155942613 | CS 7600 Hygienic Sheath | 5942610 | CS 7600 HYG SHEATHS SIZE 0 200 PCS | KQM | Camera, Surgical And Accessories | CS 7600 Hygienic Sheath | |
| 22 | 60192155942662 | CS 3700 3D I/O SCANNER CARBON GREY | 5942669 | CS 3700 3D I/O SCANNER CARBON GREY | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | CS 3700 |
| 23 | 60192155944543 | 5944541 | 5944541 | Swissmeda powered by Carestream Dental | LLZ | System, Image Processing, Radiological | 2 | Swissmeda powered by Carestream Dental |
| 24 | 60192155941306 | CS 3700 | 5941307 | CS 3700 3D I/O SCANNER ARCTIC WHITE | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | CS 3700 |
| 25 | 60192155501197 | CS 9600 | 5501192 | CS 9600 | OAS | X-Ray, Tomography, Computed, Dental | 2 | CS 9600 |
| 26 | 60192155311307 | RVG 5200 | 5311303 | RVG 5200 SIZE 2 | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 5200 |
| 27 | 60192155311291 | RVG 5200 | 5311295 | RVG 5200 SIZE 1 | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 5200 |
| 28 | 60192155302893 | SINGLE USE SLEEVES - EAR RODS | 5302898 | SINGLE USE SLEEVES - EAR RODS | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | SINGLE USE SLEEVES - EAR RODS |
| 29 | 40192155942514 | CS 7600 Smart Plate | 5942511 | CS7600 SMART PLATE SIZE 0 V2 - 4 PCS | EAM | Screen, Intensifying, Radiographic | CS 7600 Smart Plate | |
| 30 | 60192155302879 | SINGLE USE SLEEVES - PANO BITE BLOCK | 5302872 | SINGLE USE SLEEVES - PANO BITE BLOCK | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | SINGLE USE SLEEVES - PANO BITE BLOCK |
| 31 | 60192155008191 | Hygienic Sleeves Ear Cones | BDA17 | PROTECTIONS HYGIEN. AURICULAIRE 3D CSD | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | Hygienic Sleeves Ear Cones |
| 32 | 60192155008108 | RVG 5200 | CIC48 | CAPTEUR RVG 5200 T2 CSD | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 5200 |
| 33 | 60192155008092 | RVG 5200 | CIC47 | CAPTEUR RVG 5200 T1 CSD | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 5200 |
| 34 | 60192155008061 | RVG 6500 | CIC44 | CAPTEUR RVG 6500 T0 CSD | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 6500 |
| 35 | 60192155008054 | RVG 6500 | CIC43 | CAPTEUR RVG 6500 T2 CSD | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 6500 |
| 36 | 60192155008047 | RVG 6500 | CIC42 | CAPTEUR RVG 6500 T1 CSD | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG 6500 |
| 37 | 40192155942569 | CS 7600 Smart Plate | 5942560 | CS7600 SMART PLATE SIZE 4 V2 - 2 PCS | EAM | Screen, Intensifying, Radiographic | CS 7600 Smart Plate | |
| 38 | 40192155942552 | CS 7600 Smart Plate | 5942552 | CS7600 SMART PLATE SIZE 3 V2 - 4 PCS | EAM | Screen, Intensifying, Radiographic | CS 7600 Smart Plate | |
| 39 | 40192155942545 | CS 7600 Smart Plate | 5942545 | CS7600 SMART PLATE SIZE 2 V2 - 4 PCS | EAM | Screen, Intensifying, Radiographic | CS 7600 Smart Plate | |
| 40 | 40192155942538 | CS 7600 Smart Plate | 5942537 | CS7600 SMART PLATE SIZE 1 V2 - 4 PCS | EAM | Screen, Intensifying, Radiographic | CS 7600 Smart Plate | |
| 41 | 60192156851659 | CS OMS Imaging Software | 1546977 | CS OMS Imaging Software | LLZ | System, image processing, radiological | 2 | CS OMS Imaging Software |
| 42 | 60192155500237 | CS 8100SC 3D Access | 5500236 | CS 8100SC 3D ACCESS | MUH,OAS | System,x-ray,extraoral source,digital,X-ray, tomography, computed, dental | 2 | CS 8100SC 3D Access |
| 43 | 60192155319747 | CS 9300 Select | 5319744 | CS 9300 SELECT 110V | OAS | X-ray, tomography, computed, dental | 2 | CS 9300 Select |
| 44 | 60192155319716 | CS 9300 Select | 5319710 | CS 9300 SELECT 230V | OAS | X-ray, tomography, computed, dental | 2 | CS 9300 Select |
| 45 | 60192155319440 | RVG CONNECT | 5319447 | RVG CONNECT FOR US | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG CONNECT |
| 46 | 60192155313950 | RVG CONNECT | 5313952 | RVG CONNECT | EAP | UNIT, X-RAY, INTRAORAL | 2 | RVG CONNECT |
| 47 | 60192156851628 | Logicon Caries Detector | 8008690 | LOGICON SITE LIC (UP TO 10) W/IWT | MYN | Analyzer,medical image | 2 | Logicon Caries Detector |
| 48 | 60192155943720 | 5943725 | 5943725 | CS 3800 3D I/O SCANNER WIRED | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | CS 3800 Wired |
| 49 | 60192155942754 | Logicon Caries Detector | 5942750 | CSD LOGICON CARIES DETECTOR | MYN | Analyzer, Medical Image | 2 | Logicon Caries Detector |
| 50 | 60192155942136 | CS 8100SC 3D | 5942131 | CS 8100SC 3D Select | OAS,MUH | X-Ray, Tomography, Computed, Dental,System, X-Ray, Extraoral Source, Digital | 2 | CS 8100SC 3D |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B269SWR00069MD0 | SWR-00069-MD | CuattroDR System Software | CuattroDR | CUATTRO MEDICAL | |
| 2 | B269SWR00021MD0 | SWR-00021-MD | CloudDR™ Medical System Software | CloudDR™ | CUATTRO MEDICAL | |
| 3 | B229S210011 | 1 | System 2100 | MATH RESOLUTIONS, LLC | ||
| 4 | B228INTELEPACS0 | INTELEPACS | INTELEPACS | LES SYSTÈMES MÉDICAUX INTELERAD INCORPORÉE | ||
| 5 | B209XP2X00 | 2.0 | V3D-Explorer is a software application used with advanced PC hardware for the di V3D-Explorer is a software application used with advanced PC hardware for the display and 3D visualization of DICOM 3.0 compliant medical images derived from CT, MRI, PET and SPECT scans. The linear, angular and volume measurement features provided in the software for the evaluation and quantification of organ, hard and soft tissues as well as internal organ structures for lesion, mass and other anomalies. It also supports interactive segmentation of any organ. | V3D-Explorer | VIATRONIX INCORPORATED | |
| 6 | B209VC4X1X2X330 | 4.1.2.33 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 7 | B209VC4X1X2X320 | 4.1.2.32 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 8 | B209VC4X1X2X110 | 4.1.2.11 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 9 | B209VC4X1X1X150 | 4.1.1.15 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 10 | B209VC4X0X3X40 | 4.0.3.4 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 11 | B209VC4X0X3X13F0 | 4.0.3.13 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 12 | B209VC4X0X0X44F0 | 4.0.0.44 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 13 | B209VC4X0X0X360 | 4.0.0.36 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 14 | B209VC3X3X3X10 | 3.3.3.1 | V3D-Colon is a software application used with advanced PC hardware for the displ V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon. | V3D-Colon | VIATRONIX INCORPORATED | |
| 15 | B209VA2X00 | 2.0 | V3D-Vascular is a software application used with advanced PC hardware for evalua V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system based on DICOM 3.0 compliant images from CT or MR scan. | V3D-Vascular | VIATRONIX INCORPORATED | |
| 16 | B198HMV11R70 | 11.7 | HMV11R7 | HealthMyne | HEALTHMYNE, INC. | |
| 17 | B198HMV11R50 | 11.5 | HealthMyne | HEALTHMYNE, INC. | ||
| 18 | B198HMV11R40 | 11.4 | HealthMyne | HEALTHMYNE, INC. | ||
| 19 | B198HMV11R30 | 11.3 | HealthMyne | HEALTHMYNE, INC. | ||
| 20 | B198HMV11R1PK0 | 11.1 | HealthMyne | HEALTHMYNE, INC. | ||
| 21 | B198HM01220 | 12.2 | HealthMyne | HEALTHMYNE, INC. | ||
| 22 | B198HM01210 | 12.1 | HealthMyne | HEALTHMYNE, INC. | ||
| 23 | B198HM0120 | 12.0 | HMV12 | HealthMyne | HEALTHMYNE, INC. | |
| 24 | B198HM01160 | 11.6 | HealthMyne | HEALTHMYNE, INC. | ||
| 25 | B198HM0110 | 11.0 | HealthMyne | HEALTHMYNE, INC. | ||
| 26 | B198HM0102 | 10.2 | HealthMyne | HEALTHMYNE, INC. | ||
| 27 | B198HM0101 | 10.1 | HealthMyne | HEALTHMYNE, INC. | ||
| 28 | B198HM0100 | 10.0 | HealthMyne | HEALTHMYNE, INC. | ||
| 29 | B198HM0090 | 9.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 30 | B198HM0083 | 8.3 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 31 | B198HM0082 | 8.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 32 | B198HM0081 | 8.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 33 | B198HM0080 | 8.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 34 | B198HM0071 | 7.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 35 | B198HM0070 | 7.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 36 | B198HM0063 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 37 | B198HM0062 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 38 | B198HM0061 | 6.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 39 | B198HM0060 | 6.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 40 | B198HM0051 | 5.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 41 | B198HM0050 | 5.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 42 | B198HM0042 | 4.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 43 | B198HM0040 | 4.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 44 | B198HM0030 | 3.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 45 | B198HM0020 | 2.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 46 | B198HM0010 | 1.6 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
| 47 | B1984M0011R20 | 11.2 | HealthMyne | HEALTHMYNE, INC. | ||
| 48 | B193IMD3B0 | IMD-3B | ImageGrid Radiology Viewer System is a device that receives medical images and d ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | IMAGEGRID RADIOLOGY VIEWER SYSTEM | CANDELIS, INC. | |
| 49 | B193IMD3203B0 | IMD320-3B | ImageGrid Radiology Viewer System is a device that receives medical images and d ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | IMAGEGRID RADIOLOGY VIEWER SYSTEM | CANDELIS, INC. | |
| 50 | B193IMD3202B0 | IMD320-2B | ImageGrid Radiology Viewer System is a device that receives medical images and d ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants. | IMAGEGRID RADIOLOGY VIEWER SYSTEM | CANDELIS, INC. |