No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10888867217710 | AR-5050K-2 | AR-5050K-2 | K-WIRE, 2.0 X 200 MM | HTY | PIN, FIXATION, SMOOTH | 2 | Arthrex® |
2 | 00888867365452 | AR-8963PF-11S | AR-8963PF-11S | Posterior Pilon Fusion Plate, 11H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
3 | 00888867365445 | AR-8963PF-10S | AR-8963PF-10S | Posterior Pilon Fusion Plate, 10H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
4 | 00888867365438 | AR-8963PF-09S | AR-8963PF-09S | Posterior Pilon Fusion Plate, 9H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
5 | 00888867365414 | AR-8963PF-07S | AR-8963PF-07S | Posterior Pilon Fusion Plate, 7H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
6 | 00888867365421 | AR-8963PF-08S | AR-8963PF-08S | Posterior Pilon Fusion Plate, 8H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
7 | 00888867365407 | AR-8963PF-06S | AR-8963PF-06S | Posterior Pilon Fusion Plate, 6H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
8 | 00888867365391 | AR-8963PF-05S | AR-8963PF-05S | Posterior Pilon Fusion Plate, 5H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
9 | 00888867365360 | AR-8963ARF-18S | AR-8963ARF-18S | Anterolateral Pilon Fusion Plate, 18H,RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
10 | 00888867365353 | AR-8963ARF-17S | AR-8963ARF-17S | Anterolateral Pilon Fusion Plate, 17H,RT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
11 | 00888867365346 | AR-8963ARF-16S | AR-8963ARF-16S | Anterolateral Pilon Fusion Plate, 16H,RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
12 | 00888867365322 | AR-8963ARF-14S | AR-8963ARF-14S | Anterolateral Pilon Fusion Plate, 14H,RT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
13 | 00888867360501 | AR-8935-120 | AR-8935-110 | LO-PRO SCRW,TI,3.5MMX 120MM | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
14 | 00888867365315 | AR-8963ARF-13S | AR-8963ARF-13S | Anterolateral Pilon Fusion Plate, 13H,RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
15 | 00888867365308 | AR-8963ARF-12S | AR-8963ARF-12S | Anterolateral Pilon Fusion Plate, 12H,RT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
16 | 00888867365278 | AR-8963ARF-11S | AR-8963ARF-11S | Anterolateral Pilon Fusion Plate, 11H,RT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
17 | 00888867365261 | AR-8963ARF-10S | AR-8963ARF-10S | Anterolateral Pilon Fusion Plate, 10H,RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
18 | 00888867365254 | AR-8963ARF-09S | AR-8963ARF-09S | Anterolateral Pilon Fusion Plate, 9H, RT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
19 | 00888867365247 | AR-8963ARF-08S | AR-8963ARF-08S | Anterolateral Pilon Fusion Plate, 8H, RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
20 | 00888867365230 | AR-8963ARF-07S | AR-8963ARF-07S | Anterolateral Pilon Fusion Plate, 7H, RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
21 | 00888867365223 | AR-8963ARF-06S | AR-8963ARF-06S | Anterolateral Pilon Fusion Plate, 6H, RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
22 | 00888867365216 | AR-8963ARF-05S | AR-8963ARF-05S | Anterolateral Pilon Fusion Plate, 5H, RT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
23 | 00888867365193 | AR-8963ALF-18S | AR-8963ALF-18S | Anterolateral Pilon Fusion Plate, 18H,LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
24 | 00888867365186 | AR-8963ALF-17S | AR-8963ALF-17S | Anterolateral Pilon Fusion Plate, 17H,LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
25 | 00888867365179 | AR-8963ALF-16S | AR-8963ALF-16S | Anterolateral Pilon Fusion Plate, 16H,LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
26 | 00888867365162 | AR-8963ALF-15S | AR-8963ALF-15S | Anterolateral Pilon Fusion Plate, 15H,LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
27 | 00888867365155 | AR-8963ALF-14S | AR-8963ALF-14S | Anterolateral Pilon Fusion Plate, 14H,LT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
28 | 00888867365148 | AR-8963ALF-13S | AR-8963ALF-13S | Anterolateral Pilon Fusion Plate, 13H,LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
29 | 00888867365124 | AR-8963ALF-12S | AR-8963ALF-12S | Anterolateral Pilon Fusion Plate, 12H,LT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
30 | 00888867365117 | AR-8963ALF-11S | AR-8963ALF-11S | Anterolateral Pilon Fusion Plate, 11H,LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
31 | 00888867365100 | AR-8963ALF-10S | AR-8963ALF-10S | Anterolateral Pilon Fusion Plate, 10H,LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
32 | 00888867365094 | AR-8963ALF-09S | AR-8963ALF-09S | Anterolateral Pilon Fusion Plate, 9H, LT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
33 | 00888867365087 | AR-8963ALF-08S | AR-8963ALF-08S | Anterolateral Pilon Fusion Plate, 8H, LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
34 | 00888867365070 | AR-8963ALF-07S | AR-8963ALF-07S | Anterolateral Pilon Fusion Plate, 7H, LT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
35 | 00888867365063 | AR-8963ALF-06S | AR-8963ALF-06S | Anterolateral Pilon Fusion Plate, 6H, LT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
36 | 00888867365056 | AR-8963ALF-05S | AR-8963ALF-05S | Anterolateral Pilon Fusion Plate, 5H, LT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
37 | 00888867364820 | AR-8963PF-15 | AR-8963PF-15 | Posterior Pilon Fusion Plate, 15H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
38 | 00888867364813 | AR-8963PF-14 | AR-8963PF-14 | Posterior Pilon Fusion Plate, 14H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
39 | 00888867364806 | AR-8963PF-13 | AR-8963PF-13 | Posterior Pilon Fusion Plate, 13H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
40 | 00888867364790 | AR-8963PF-12 | AR-8963PF-12 | Posterior Pilon Fusion Plate, 12H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
41 | 00888867364783 | AR-8963PF-11 | AR-8963PF-11 | Posterior Pilon Fusion Plate, 11H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
42 | 00888867364776 | AR-8963PF-10 | AR-8963PF-10 | Posterior Pilon Fusion Plate, 10H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
43 | 00888867364769 | AR-8963PF-09 | AR-8963PF-09 | Posterior Pilon Fusion Plate, 9H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
44 | 00888867364752 | AR-8963PF-08 | AR-8963PF-08 | Posterior Pilon Fusion Plate, 8H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
45 | 00888867364745 | AR-8963PF-07 | AR-8963PF-07 | Posterior Pilon Fusion Plate, 7H | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
46 | 00888867364738 | AR-8963PF-06 | AR-8963PF-06 | Posterior Pilon Fusion Plate, 6H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
47 | 00888867364721 | AR-8963PF-05 | AR-8963PF-05 | Posterior Pilon Fusion Plate, 5H | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
48 | 00888867364615 | AR-8963ARF-10 | AR-8963ARF-10 | Anterolateral Pilon Fusion Plate, 10H,RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
49 | 00888867364608 | AR-8963ARF-09 | AR-8963ARF-09 | Anterolateral Pilon Fusion Plate, 9H, RT | HRS,HWC | Plate, fixation, bone,Screw, fixation, bone | 2 | Arthrex® |
50 | 00888867364691 | AR-8963ARF-18 | AR-8963ARF-18 | Anterolateral Pilon Fusion Plate, 18H,RT | HWC,HRS | Screw, fixation, bone,Plate, fixation, bone | 2 | Arthrex® |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B229S210011 | 1 | System 2100 | MATH RESOLUTIONS, LLC | ||
2 | B228INTELEPACS0 | INTELEPACS | INTELEPACS | LES SYSTÈMES MÉDICAUX INTELERAD INCORPORÉE | ||
3 | 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 | |
4 | 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 | |
5 | 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 | |
6 | 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 | |
7 | 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 | |
8 | 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 | |
9 | 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 | |
10 | 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 | |
11 | 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 | |
12 | 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 | |
13 | 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 | |
14 | B198HMV11R70 | 11.7 | HMV11R7 | HealthMyne | HEALTHMYNE, INC. | |
15 | B198HMV11R50 | 11.5 | HealthMyne | HEALTHMYNE, INC. | ||
16 | B198HMV11R40 | 11.4 | HealthMyne | HEALTHMYNE, INC. | ||
17 | B198HMV11R30 | 11.3 | HealthMyne | HEALTHMYNE, INC. | ||
18 | B198HMV11R1PK0 | 11.1 | HealthMyne | HEALTHMYNE, INC. | ||
19 | B198HM01220 | 12.2 | HealthMyne | HEALTHMYNE, INC. | ||
20 | B198HM01210 | 12.1 | HealthMyne | HEALTHMYNE, INC. | ||
21 | B198HM0120 | 12.0 | HMV12 | HealthMyne | HEALTHMYNE, INC. | |
22 | B198HM01160 | 11.6 | HealthMyne | HEALTHMYNE, INC. | ||
23 | B198HM0110 | 11.0 | HealthMyne | HEALTHMYNE, INC. | ||
24 | B198HM0102 | 10.2 | HealthMyne | HEALTHMYNE, INC. | ||
25 | B198HM0101 | 10.1 | HealthMyne | HEALTHMYNE, INC. | ||
26 | B198HM0100 | 10.0 | HealthMyne | HEALTHMYNE, INC. | ||
27 | B198HM0090 | 9.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
28 | B198HM0083 | 8.3 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
29 | B198HM0082 | 8.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
30 | B198HM0081 | 8.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
31 | B198HM0080 | 8.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
32 | B198HM0071 | 7.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
33 | B198HM0070 | 7.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
34 | B198HM0063 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
35 | B198HM0062 | 6.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
36 | B198HM0061 | 6.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
37 | B198HM0060 | 6.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
38 | B198HM0051 | 5.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
39 | B198HM0050 | 5.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
40 | B198HM0042 | 4.2 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
41 | B198HM0040 | 4.1 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
42 | B198HM0030 | 3.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
43 | B198HM0020 | 2.0 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
44 | B198HM0010 | 1.6 | HealthMyne QIDS | HEALTHMYNE, INC. | ||
45 | B1984M0011R20 | 11.2 | HealthMyne | HEALTHMYNE, INC. | ||
46 | 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. | |
47 | 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. | |
48 | 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. | |
49 | B193IMD3201B0 | IMD320-1B | 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 | B193IMD2B0 | IMD-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. |