No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 06938396497002 | CR-30A | CR Series Trolley, CR Series Cart, used to transport medical ultrasound machines. | BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 1 | SIUI | |
2 | 06938396493288 | V6LN | Endocavity Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
3 | 06938396423001 | Apogee 2300 | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
4 | 06938396421007 | Apogee 2100 | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
5 | 06938396412005 | Apogee 1200 | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
6 | 06938396411008 | Apogee 1100 | Digital Color Doppler Ultrasound Imaging System | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | SIUI | |
7 | 06938396410094 | Apogee 1000B/W | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
8 | 06938396410087 | Apogee 1000Exp | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
9 | 06938396410070 | Apogee 1000Neo | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
10 | 06938396410063 | SR-1000S | Portable DR Imaging System | IZL,MQB,LLZ | System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),Syste System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, Image Processing, Radiological | 2 | SIUI | |
11 | 06938396410056 | Apogee 1000Lite | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
12 | 06938396410049 | SR-1000 | Portable DR Imaging System | IZL,MQB,LLZ | System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),Syste System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, Image Processing, Radiological | 2 | SIUI | |
13 | 06938396410001 | Apogee 1000 | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
14 | 06938396409005 | CTS-900 | Digital Ultrasound Imaging System | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
15 | 06938396404857 | CTS-485 | Ultrasound Imaging System | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
16 | 06938396404154 | CTS-415 | Ultrasound Imaging System | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
17 | 06938396400811 | Apogee 8U | Digital Color Doppler Ultrasound Imaging System | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | SIUI | |
18 | 06938396400576 | Apogee 2100 Plus | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
19 | 06938396400545 | Apogee 5G | Digital Color Doppler Ultrasound Imaging System | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | SIUI | |
20 | 06938396400521 | Apogee 5T | Digital Color Doppler Ultrasound Imaging System | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | SIUI | |
21 | 06938396400439 | SR-2100 | Portable DR Imaging System | IZL,MQB,LLZ | System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),Syste System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, Image Processing, Radiological | 2 | SIUI | |
22 | 06938396400422 | SR-1100S | Portable DR Imaging System | IZL,MQB,LLZ | System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),Syste System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, Image Processing, Radiological | 2 | SIUI | |
23 | 06938396400415 | SR-1100 | Portable DR Imaging System | IZL,MQB,LLZ | System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),Syste System, X-Ray, Mobile,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, Image Processing, Radiological | 2 | SIUI | |
24 | 06938396400408 | ECBP-5 | Endocavity BiplaneTransducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
25 | 06938396400132 | Apogee 1G | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
26 | 06938396400125 | Apogee 1T | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
27 | 06938396400118 | Apogee 1U | Digital Color Doppler Ultrasound Imaging System | IYN,IYO | System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | SIUI | |
28 | 06938396491192 | L8LC | Linear Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
29 | 06938396490126 | C3I40 | Convex Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
30 | 06938396491147 | L7I50 | Linear Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
31 | 06938396490096 | C3L60B | Convex Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
32 | 06938396493219 | V6LF | Endocavity Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
33 | 06938396491055 | L7L38G | Linear Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
34 | 06938396491024 | L8L38C | Linear Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
35 | 06938396491116 | L7L38B | Linear Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
36 | 06938396495084 | C5LN | Volume Probe | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
37 | 06938396495053 | C5LF | Convex Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
38 | 06938396495046 | C5L40C | Convex Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
39 | 06938396495022 | 4DL40G | Convex Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
40 | 06938396494070 | P5FN | Phased Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
41 | 06938396494063 | P5FC | Phased Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
42 | 06938396494056 | P3F14G | Phased Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
43 | 06938396494049 | P3FN | Phased Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
44 | 06938396494032 | P3FC | Phased Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
45 | 06938396494018 | P3F14C | Phased Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
46 | 06938396493301 | ECBN | Endocavity BiplaneTransducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
47 | 06938396493295 | U5LN | Endocavity Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
48 | 06938396492250 | C6LN | Micro-Convex Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
49 | 06938396492205 | C6LC | Convex Array Transducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI | |
50 | 06938396491338 | ECBP-2 | Endocavity BiplaneTransducer | ITX | Transducer, Ultrasonic, Diagnostic | 2 | SIUI |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03701440100172 | 62833765 | ArtPiX Mobile EZ2GO | THALES AVS FRANCE SAS | ||
2 | 03701440100035 | 63111976 | Duet DRF | THALES AVS FRANCE SAS | ||
3 | 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 | |
4 | 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 | |
5 | 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 |
6 | 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 | |
7 | 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 | |
8 | 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 | |
9 | 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 | |
10 | 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 | |
11 | 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 | |
12 | 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 | |
13 | 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 | |
14 | 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 | |
15 | 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 | |
16 | 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 | |
17 | 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 | |
18 | 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 | |
19 | 03665587000095 | 6.1 | MEDWS | MED.E.COM | ||
20 | 03665587000088 | 5.6 | MEDWS | MED.E.COM | ||
21 | 03665587000071 | 5.4 | MEDWS | MED.E.COM | ||
22 | 03665587000064 | 5.2 | MEDWS | MED.E.COM | ||
23 | 03665587000057 | 5.0 | MEDWS | MED.E.COM | ||
24 | 03665587000033 | 4.18 | MEDWS | MED.E.COM | ||
25 | 03665587000026 | 4.17 | MEDWS | MED.E.COM | ||
26 | 03665587000019 | 4.14 | MEDWS | MED.E.COM | ||
27 | 03665587000002 | 4.15 | MEDWS | MED.E.COM | ||
28 | 03665134000714 | KSOF-2602 | PROMAP – 3D PROSTATE SUITE | KOELIS | ||
29 | 03665134000684 | KURO-3000-3 | TRINITY | KOELIS | ||
30 | 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 | |
31 | 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 | |
32 | 03663999000054 | Software 1.8 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
33 | 03663999000047 | Workstation 1.8 | sterEOS workstation | sterEOS® | EOS IMAGING | |
34 | 03663999000030 | Software 1.6 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
35 | 03663999000023 | Workstation 1.6 | sterEOS workstation | sterEOS® | EOS IMAGING | |
36 | 03661489709067 | 0100011575 | e-Ortho Shoulder Software | FOURNITURES HOSPITALIERES INDUSTRIE | ||
37 | EKAV101244750 | 11 | 1.012.4475 | Software | DEXIS™ Software | DEXIS LLC |
38 | EKAV101152780 | 1.011.5278 | FP 0203 | Handheld x-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
39 | EKAV101135330 | 11 | 10124479 | Software | DEXIS™ Software | DEXIS LLC |
40 | EKAV101037680 | 3 | VIXWINPL | Imaging software | Gendex VixWin™ imaging software | GENDEX CORP. |
41 | EKAV101034120 | 9 | PLU238 | Enterprise | DEXIS™ Software | DEXIS LLC |
42 | EKAV101034110 | 9 | PLU349 | US & International | DEXIS™ Software | DEXIS LLC |
43 | EKAV101034090 | 9 | PLU235 | Animal | DEXIS™ Software | DEXIS LLC |
44 | EKAV101034080 | 9 | PLU236 | Forensic | DEXIS™ Software | DEXIS LLC |
45 | EKAV100879340 | 10 | 1.008.7934 | DEXIS 10 (DEXIS Imaging Suite) | DEXIS LLC | |
46 | EKAV085004710 | 0.850.0471 | FP 0202 | Handheld x-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
47 | EKAV085004700 | 0.850.0470 | FP 0204 | Handheld x-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
48 | EKAV085001120 | 0.850.0112 | AP 0200 | Handheld X-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
49 | EKAV085000300 | 0.850.0030 | FP 0201 | Handheld X-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
50 | 00935712300004 | Rover | MXU-RV01 | The device is designed to perform radiographic x-ray examinations on pediatric a The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas | Micro-X | MICRO-X LIMITED |