No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04056869003382 | 10036500 | ITX | Transducer, ultrasonic, diagnostic | 2 | P10 Transducer | ||
2 | 04056869002392 | 10183311 | LLZ | System, image processing, radiological | 2 | Scenium SPECT_V | ||
3 | 04056869001173 | 10275007 | KPS | System, tomography, computed, emission | 2 | Symbia_T | ||
4 | 04056869267081 | 11503525 | ITX | Transducer, ultrasonic, diagnostic | 2 | CW8 Transducer | ||
5 | 04056869062020 | 10787117 | ITX | Transducer, ultrasonic, diagnostic | 2 | 9EC4 Transducer | ||
6 | 04056869274959 | 11289565 | ITX | Transducer, ultrasonic, diagnostic | 2 | 7VC2 Transducer | ||
7 | 04056869002866 | 08266709 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | ||
8 | 04056869053882 | 11286583 | 59645 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | |
9 | 04056869053875 | 11286582 | 8248186 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | |
10 | 04056869173566 | 11148775 | 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 | ACUSON Sequoia Diagnostic Ultrasound System | ||
11 | 04056869109466 | 11336164 | ITX | Transducer, ultrasonic, diagnostic | 2 | BP10-3 Transducer | ||
12 | 04056869264769 | 11364753 | KPS | System, tomography, computed, emission | 2 | Symbia Pro.specta X7 | ||
13 | 04056869238265 | 11361589 | ITX | Transducer, ultrasonic, diagnostic | 2 | 13L4 Transducer | ||
14 | 04056869053813 | 11286576 | 59644 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
15 | 04056869053806 | 11286575 | 58525 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
16 | 04056869052076 | 11014579 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | ||
17 | 04056869051925 | 11319697 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | ||
18 | 04056869030005 | 11284381 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Acuson NX2 Diagnostic Ultrasound System | ||
19 | 04056869027258 | 11014031 | ITX | Transducer, ultrasonic, diagnostic | 2 | VFX9-4 Transducer | ||
20 | 04056869027227 | 10787446 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | P10 Handheld Ultrasound system | ||
21 | 04056869006833 | 11149925 | LLZ | System, image processing, radiological | 2 | sUSBA Software | ||
22 | 04056869006512 | 10852687 | 9600153000 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA023E Transducer | |
23 | 04056869006505 | 10852686 | 9600165000 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA230E Transducer | |
24 | 04056869005577 | 10784498 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | ||
25 | 04056869005560 | 10784497 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | ||
26 | 04056869005379 | 10033454 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | ||
27 | 04056869005287 | 08267986 | 8266709 | ITX | Transducer, ultrasonic, diagnostic | 2 | 10V4 Transducer | |
28 | 04056869005201 | 08259645 | 59645 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer | |
29 | 04056869005195 | 08259644 | 59644 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
30 | 04056869005188 | 08259643 | 59643 | ITX | Transducer, ultrasonic, diagnostic | 2 | 4C1 Transducer | |
31 | 04056869005102 | 08247447 | 47447 | ITX | Transducer, ultrasonic, diagnostic | 2 | 8L5 Transducer | |
32 | 04056869005003 | 05918102 | 59180 | ITX | Transducer, ultrasonic, diagnostic | 2 | CX5-2 TRANSDUCER-E | |
33 | 04056869004549 | 10349999 | ITX | Transducer, ultrasonic, diagnostic | 2 | MC9-4 Transducer | ||
34 | 04056869004419 | 05726625 | ITX | Transducer, ultrasonic, diagnostic | 2 | 3.5C40S Transducer | ||
35 | 04056869004303 | 11235411 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Acuson NX3 Elite Diagnostic Ultrasound System | ||
36 | 04056869004297 | 11235612 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Acuson NX3 Diagnostic Ultrasound System | ||
37 | 04056869004266 | 10855958 | OBJ | Catheter, ultrasound, intravascular | 2 | AcuNav Volume Ultrasound Catheter | ||
38 | 04056869004259 | 10852646 | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | ACUSON P300 Diagnostic Ultrasound System | ||
39 | 04056869003825 | 11013911 | ITX | Transducer, ultrasonic, diagnostic | 2 | EV-8C4 Transducer | ||
40 | 04056869003818 | 11013910 | ITX | Transducer, ultrasonic, diagnostic | 2 | EV-8C4 Transducer | ||
41 | 04056869003733 | 08267218 | 8267218 | ITX | Transducer, ultrasonic, diagnostic | 2 | 7L3 Transducer | |
42 | 04056869003627 | 05936237 | 5936237 | ITX | Transducer, ultrasonic, diagnostic | 2 | VFX9-4 Transducer | |
43 | 04056869003528 | 10853679 | LLZ | System, image processing, radiological | 2 | syngo Ultrasound Workplace | ||
44 | 04056869003504 | 10433921 | LLZ | System, image processing, radiological | 2 | syngo SC2000 Workplace | ||
45 | 04056869003443 | 11147262 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA230E Transducer | ||
46 | 04056869003429 | 11147260 | ITX | Transducer, ultrasonic, diagnostic | 2 | PA023E Transducer | ||
47 | 04056869003399 | 07472272 | 7472272 | ITX | Transducer, ultrasonic, diagnostic | 2 | P10-4 Transducer | |
48 | 04056869003252 | 07465672 | 7465672 | ITX | Transducer, ultrasonic, diagnostic | 2 | CH6-2 Transducer | |
49 | 04056869003153 | 08241116 | 8241116 | ITX | Transducer, ultrasonic, diagnostic | 2 | 8L5 Transducer | |
50 | 04056869003092 | 08248186 | 8248186 | ITX | Transducer, ultrasonic, diagnostic | 2 | 6C2 Transducer |
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. |