No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884838081536 | 45353038409 | Sentinelle MR 1.5T Breast Imaging Table | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
2 | 00884838073159 | 98960320913 | Grid Plate, Enhanced Access, lat. | GDF | GUIDE, NEEDLE, SURGICAL | 1 | Invivo | |
3 | 00884838072831 | 98960320335 | Coax Needle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
4 | 00884838065673 | 45353025228 | dS Wrist 8CH 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
5 | 00884838081550 | 784015 | UroNav Fusion Biopsy Software | JAK | System, x-ray, tomography, computed | 2 | Invivo | |
6 | 00884838067417 | 45353036082 | SENSE XL Torso Coil | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
7 | 00884838066854 | 45353028072 | dS Breast 16CH 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
8 | 00884838067240 | 45353031542 | HD 8CH Wrist Array | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
9 | 00884838067202 | 45353030472 | 1.5T HD T/R Knee Coil (flat base) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
10 | 00884838067189 | 45353031519 | HD 8CH Wrist Array | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
11 | 00884838067134 | 107629 | HD 8Ch NV Array | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
12 | 00884838067110 | 106614 | HD T/R Quad Extremity Coil | LNH | System, nuclear magnetic resonance imaging | 2 | Invivo | |
13 | 00884838067103 | 109183 | HD 8CH Foot Ankle Coil (Receive Only) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
14 | 00884838067097 | 585TO-64 | Phased Array ABFLEX Coil | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
15 | 00884838067042 | 106453 | HD 4Ch Breast Array (Receive Only) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
16 | 00884838066908 | 45353032243 | dS Flex-S | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
17 | 00884838105348 | 4598-018-57611 | dS 1.5T Medial Plug | MOS | Coil, Magnetic Resonance, Specialty | 2 | Sentinelle | |
18 | 00884838072978 | 98960320349 | Needle Sleeve | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
19 | 00884838098497 | 459801730021 | dS Knee 16 Ch 1.5T | MOS | Coil, Magnetic Resonance, Specialty | 2 | Invivo | |
20 | 00884838065390 | 45353031035 | SENSE MSK M 8CH 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
21 | 00884838086166 | 45980129063 | dS Knee 8Ch 3.0T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
22 | 00884838066953 | 45353033812 | SENSE Torso 8 | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
23 | 00884838066205 | 103345 | Breast Biopsy Array Coil | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
24 | 00884838081529 | 101759 | 1.5T KFA with coil ID | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
25 | 00884838081512 | 472GE-42 | 1.0T Quadrature Lower Extremity Coil | LNH | System, nuclear magnetic resonance imaging | 2 | Invivo | |
26 | 00884838073227 | 98960320446 | Bone Biopsy Set, manual | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
27 | 00884838073210 | 98960320370 | Handle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
28 | 00884838073203 | 98960320369 | Working Tube Set | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
29 | 00884838073197 | 98960320368 | Bone Biopsy Drill Set, manual | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
30 | 00884838073180 | 98960320365 | Bone Biopsy Set, manual | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
31 | 00884838073173 | 98960320914 | Lateral Grid dS Breast 16CH I/T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
32 | 00884838073166 | 98960320915 | Medial Grid dS Breast 16CH I/T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
33 | 00884838073142 | 98960320912 | Grid Plate, Enhanced Access, med. | GDF | GUIDE, NEEDLE, SURGICAL | 1 | Invivo | |
34 | 00884838073135 | 98960320910 | Pillar Immobilization Plate | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
35 | 00884838072848 | 98960320336 | Coax Needle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
36 | 00884838072824 | 98960320334 | Coax Needle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
37 | 00884838065666 | 100313 | Breast Array Coil (Receive Only) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
38 | 00884838065659 | 45353005761 | SENSE Head Coil 1.5T/8CH | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
39 | 00884838085510 | 784016 | DynaLync Prostate | OUG | Medical device data system | 1 | Invivo | |
40 | 00884838081673 | 45353033613 | dS HiRes Hand/Wrist 16Ch 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
41 | 00884838081666 | 45980077811 | dS Small Extremity 16ch 3.0T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
42 | 00884838081659 | 45980087863 | dS Small Extremity 16Ch 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
43 | 00884838081635 | 45353033611 | dS Shoulder 16Ch 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
44 | 00884838081628 | 10606922 | 2 Channel Endo Coil Array for Siemens 3T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
45 | 00884838081611 | 10606920 | Prostate 2 MR Coil 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
46 | 00884838081581 | 45353038361 | Breast MRI 8ch Tabletop for Siemens 3T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
47 | 00884838081604 | 45353038386 | Breast MRI 16ch Tabletop for Siemens 3T | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Invivo | |
48 | 00884838081598 | 45353038382 | Breast MRI 16ch Tabletop for Siemens 1.5T | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Invivo | |
49 | 00884838081574 | 45353038349 | Breast MRI 8ch Tabletop for Siemens 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
50 | 00884838081567 | 45353038366 | Breast MRI 4ch Tabletop for Siemens 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03770016198004 | 1.X | QyScore | QYNAPSE | ||
2 | 03760297030209 | FXSPS001 | Planning software for total shoulder arthroplasty | FX Shoulder Positioning System | PIXEE MEDICAL | |
3 | 03760264690115 | 3.2.1 | M'Ath PACS | I M T | ||
4 | 03760264690061 | 3.2.1 SR | M'Ath | I M T | ||
5 | 03760263520024 | 6.0 | LMS-Liver is an image analysis software application for evaluating CT images cov LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. | LMS-Liver | MEDIAN TECHNOLOGIES | |
6 | 03760263520017 | 6.0 | LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qual LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:- visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)- generate automatic reports. | LMS-Lung/TRACK | MEDIAN TECHNOLOGIES | |
7 | 03760262480015 | 3.1 | EndoSize | THERENVA | ||
8 | 03700757200858 | 1.x | spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | spineEOS | ONEFIT MEDICAL | |
9 | 03700757200834 | 3.x | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL | |
10 | 03700757200827 | 2.x | / | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL |
11 | 03700757200544 | 1.1 | spineEOS allows surgeons to perform preoperative surgical planning of spine surg spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | spineEOS | ONEFIT MEDICAL | |
12 | 03700757200520 | 2.5 | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL | |
13 | 03700757200506 | 1.0 | kneeEOS allows surgeons to perform preoperative surgical planning of total kneea kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. | kneeEOS | ONEFIT MEDICAL | |
14 | 03700719700471 | MYRIAN 2.9 | Myrian® is a medical software for processing, management, advanced visualization Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use. | MYRIAN | INTRASENSE | |
15 | 03700719700464 | MYRIAN 2.7.6 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
16 | 03700719700457 | MYRIAN 2.8 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
17 | 03700719700440 | MYRIAN 2.7 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
18 | 03700719700433 | MYRIAN 2.6 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
19 | 03700719700426 | MYRIAN 2.5 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
20 | 03700719700419 | MYRIAN 2.4 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
21 | 03700719700402 | MYRIAN 2.3 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
22 | 03700719700396 | MYRIAN 2.2 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
23 | 03700719700013 | MYRIAN 2.1 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
24 | 03665587000095 | 6.1 | MEDWS | MED.E.COM | ||
25 | 03665587000088 | 5.6 | MEDWS | MED.E.COM | ||
26 | 03665587000071 | 5.4 | MEDWS | MED.E.COM | ||
27 | 03665587000064 | 5.2 | MEDWS | MED.E.COM | ||
28 | 03665587000057 | 5.0 | MEDWS | MED.E.COM | ||
29 | 03665587000033 | 4.18 | MEDWS | MED.E.COM | ||
30 | 03665587000026 | 4.17 | MEDWS | MED.E.COM | ||
31 | 03665587000019 | 4.14 | MEDWS | MED.E.COM | ||
32 | 03665587000002 | 4.15 | MEDWS | MED.E.COM | ||
33 | 03665134000714 | KSOF-2602 | PROMAP – 3D PROSTATE SUITE | KOELIS | ||
34 | 03665134000684 | KURO-3000-3 | TRINITY | KOELIS | ||
35 | 03665134000578 | KURO-4000 | A system based on the PROMAP – 3D Prostate Suite range intended to define prosta A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. | MR DRAW | KOELIS | |
36 | 03665134000035 | KURO3000-2 | A mobile workstation composed by a central unit with ultrasound beamformer, a A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart,Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. | TRINITY | KOELIS | |
37 | 03663999000054 | Software 1.8 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
38 | 03663999000047 | Workstation 1.8 | sterEOS workstation | sterEOS® | EOS IMAGING | |
39 | 03663999000030 | Software 1.6 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
40 | 03663999000023 | Workstation 1.6 | sterEOS workstation | sterEOS® | EOS IMAGING | |
41 | 03661489709067 | 0100011575 | e-Ortho Shoulder Software | FOURNITURES HOSPITALIERES INDUSTRIE | ||
42 | EKAV101244750 | 11 | 1.012.4475 | Software | DEXIS™ Software | DEXIS LLC |
43 | EKAV101135330 | 11 | 10124479 | Software | DEXIS™ Software | DEXIS LLC |
44 | EKAV101037680 | 3 | VIXWINPL | Imaging software | Gendex VixWin™ imaging software | GENDEX CORP. |
45 | EKAV101034120 | 9 | PLU238 | Enterprise | DEXIS™ Software | DEXIS LLC |
46 | EKAV101034110 | 9 | PLU349 | US & International | DEXIS™ Software | DEXIS LLC |
47 | EKAV101034090 | 9 | PLU235 | Animal | DEXIS™ Software | DEXIS LLC |
48 | EKAV101034080 | 9 | PLU236 | Forensic | DEXIS™ Software | DEXIS LLC |
49 | EKAV100879340 | 10 | 1.008.7934 | DEXIS 10 (DEXIS Imaging Suite) | DEXIS LLC | |
50 | 00889024486782 | 20-8017-038-00 | 20-8017-038-00 | X-PSI™ | ORTHOSOFT INC |