No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00763000138820 | 9732176 | KIT 9732176 TOUCH-N-GO | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
2 | 00763000053994 | 9734404 | AWL 9734404 TIP | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
3 | 00763000053895 | 9734296 | TAP 9734296 3.75 | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
4 | 00763000053819 | 9734402 | PROBE 9734402 LUMBAR | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
5 | 00763000053802 | 9734403 | PROBE 9734403 THORACIC | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
6 | 00763000052966 | 9732565 | Dilator, 9732565, 100mm | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
7 | 00643169843929 | 9735742 | SFW 9735742 STEALTH 3D ENT | PGW | Ear, Nose, and Throat Stereotaxic Instrument | 2 | NA | |
8 | 00885074314440 | 9731250 | PROBE 9731250 ENV CURVED SUCTION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
9 | 00885074549811 | 9732468 | INSERT 9732468 HIP NAVIGATION TRAY | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
10 | 00885074549781 | 9732664 | TRAY, 9732664, HIP NAVIGATION INSTR | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
11 | 00885074545066 | 9732389 | WRKSTN, 9732389, STEALTHSTATION INAV II | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
12 | 00885074530369 | 9732626 | PINS 9732626 FIXATOR 3IN AND 5IN | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
13 | 00885074517261 | 9732374XOM | INSTRUMENT 9732374XOM OSTIUM SEEKER ENV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
14 | 00885074515427 | 9732180 | CD, 9732180, LIBRARY - STEALTHLINK | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
15 | 00885074515410 | 9732178 | KIT, 9732178, STEALTHLINK | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
16 | 00885074511375 | 9732540 | SET 9732540 U ITHR INSTRUMENTS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
17 | 00885074511184 | 9732566 | ADAPTER 9732566 SHORT BED RAIL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
18 | 00885074510484 | 9732463 | CD 9732463 INSTALL U ITHR INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
19 | 00885074498140 | 9660246 | ADAPTER, 9660246, PATIENT TRACKER RADIOL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
20 | 00885074485058 | 9732576 | SFTWR 9732576 SECOND TOUCHSITE AUTOINS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
21 | 00885074447186 | 9732245 | FOOTSWITCH 9732245 WITH CABLE USB | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
22 | 00885074445465 | 9732430 | SOFTWARE, 9732430, SPINE UNIFIED | OLO,MAX | Orthopedic stereotaxic instrument,Intervertebral fusion device with bone graft, lumbar | 2 | N/A | |
23 | 00885074435558 | 9731958 | INSTALL DVD 9731958 SPINE TOOLSA^ | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
24 | 00885074416922 | 9732296 | PROBE 9732296 LONG POINTER 2.5 BALL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
25 | 00885074403755 | 9732244 | SW 9732244 3D SPINE APPLICATION INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
26 | 00885074368856 | 9731883 | RACK 9731883 POLESTAR ASSY INT'L | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
27 | 00885074368825 | 9731873 | CART 9731873 POLESTAR NAVIGATION ASSY | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
28 | 00885074366722 | 9731838 | HARDWARE 9731838 POLESTAR INTEGRATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
29 | 00885074366715 | 9731839 | VIEW STATION 9731839 ASSEMBLED | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
30 | 00885074366661 | 9731844 | CART 9731844 POLESTAR VIEW STATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
31 | 00885074361505 | 9731909 | ROD, 9731909, DETACHABLE PRF | LNH | System, nuclear magnetic resonance imaging | 2 | N/A | |
32 | 00885074348827 | 9732236 | SPRING PADDLE 9732236 PASSIVE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
33 | 00885074338255 | 9732221 | DG KIT 9732221 SHORT DRILL GUIDE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
34 | 00885074328225 | 9732176 | KIT, 9732176, TOUCH-N-GO | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
35 | 00885074328195 | 9731965 | PROBE 9731965 BALL TIP ASSY - 4.3mm | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
36 | 00885074281179 | 9732010 | WORKSTATION 9732010 DBS TDS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
37 | 00885074262086 | 9731968 | TRAY, 9731968, ORTHONAV STERILIZATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
38 | 00885074240121 | 9731833 | DRIVER 9731833 1/4" BALL HEX | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
39 | 00885074240114 | 9731450 | HOLDER 9731450 MOBILE LOCALIZER | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
40 | 00885074240091 | 9731203 | FIELD GENERATOR 9731203 EM MOBILE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
41 | 00885074227337 | 9731808 | TRAY, 9731808 STERILIZATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
42 | 00885074203027 | 9731567XOM | ARRAY 9731567XOM SURETRAK2 ORANGE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
43 | 00885074102641 | 9731110 | HANDLE 9731110 IMAGE GUIDED | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
44 | 00885074140735 | 9731617 | MW 9731617 VM900 PTR ONLY INTF PLUS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
45 | 00885074129327 | 9731464 | BRACKET ADAPTER 9731464 MOLLER 20-1000 | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
46 | 00885074098685 | 9731581 | ACC 9731581 INST TRAY ASSY, INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
47 | 00885074098586 | 9731238 | WORKSTATION 9731238 50901CONFIG EU | HAW | Neurological stereotaxic Instrument | 2 | NA | |
48 | 00885074098579 | 9731217 | WORKSTATION 9731217 50901 CONFIGURED US | HAW | Neurological stereotaxic Instrument | 2 | NA | |
49 | 00885074079448 | 9732110 | SFTWR 9732110 FRAMELINK WORKSTATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
50 | 00885074079318 | 9731257 | WORKSTATION 9731257 DBS TDS UST | HAW | Neurological stereotaxic Instrument | 2 | N/A |
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. |