| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00667147001545 | V8 | PDDS | Polaroid DDS software | LLZ | System, Image Processing, Radiological | 2 | Polaroid DDS |
| 2 | 00667147000227 | FSM18 | SILICONE WIDE APPLICATION TIPS (100) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FAST SPLINT MATRIX | |
| 3 | 00667147000203 | FSM14 | ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FAST SPLINT MATRIX | |
| 4 | 00667147000197 | FSM12 | COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FAST SPLINT MATRIX | |
| 5 | 00667147000180 | FSM08 | COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FAST SPLINT MATRIX | |
| 6 | 66714700001255 | FSM24 | BOND RESIN (5ML) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FAST SPLINT MATRIX | |
| 7 | 66714700001231 | FSM18 | SILICONE WIDE APPLICATION TIPS (100) | EBI | Resin, Denture, Relining, Repairing, Rebasing | FAST SPLINT MATRIX | ||
| 8 | 66714700001217 | FSM14 | ADHESIVE WAX STRIPS FOR FIBERS 1:4 (8-55MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | FAST SPLINT MATRIX | ||
| 9 | 66714700001200 | FSM12 | COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | FAST SPLINT MATRIX | ||
| 10 | 66714700001194 | FSM08 | COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | FAST SPLINT MATRIX | ||
| 11 | 00667147000067 | CST50 | FIBER FORCECST DENTURE COMPLETE KIT | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 12 | 00667147000029 | CST14 | FIBER FORCE CSTFLOW PINK RESIN (3ML) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 13 | 00667147000012 | CST12 | FIBER FORCE CSTPINK FIBERS 1:4 HYBRID (300MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 14 | 00667147000005 | CST10 | FIBER FORCE CSTPINK FIBERS 1:6 hybrid (450 MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 15 | 66714700001064 | CST50 | FIBER FORCECST DENTURE COMPLETE KIT | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 16 | 66714700001026 | CST14 | FIBER FORCE CST FLOW PINK RESIN (3ML) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 17 | 66714700001019 | CST12 | FIBER FORCE CST PINK FIBERS 1:4 HYBRID (300MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 18 | 66714700001002 | CST10 | FIBER FORCE CSTPINK FIBERS 1:6 HYBRID (450MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | CST | |
| 19 | 00667147000302 | BDT31 | BIOLIGHT DUAL REAMER #1 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 20 | 00667147001309 | BDT25 | BIOLIGHT DUAL REAMER #0.5 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 21 | 00667147000449 | BST50 | BIOLIGHT ST EPOXY-FREE FIBER POSTS INTRO KIT | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 22 | 00667147000425 | BST250 | BIOLIGHT ST REAMER 1.50 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 23 | 00667147000418 | BST235 | BIOLIGHT ST REAMER 1.35 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 24 | 00667147000401 | BST220 | BIOLIGHT ST REAMER 1.20 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 25 | 00667147000395 | BST200 | BIOLIGHT ST REAMER 1.00 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 26 | 00667147000371 | BST150 | BIOLIGHT ST REFILL 1.50 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 27 | 00667147000364 | BST135 | BIOLIGHT ST REFILL 1.35MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 28 | 00667147000357 | BST120 | BIOLIGHT ST REFILL 1.20MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 29 | 00667147000340 | BST100 | BIOLIGHT ST REFILL 1.00 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 30 | 00667147000333 | BDT40 | BIOLIGHT DUAL ADVANCED FIBER POSTS INTRO KIT | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 31 | 00667147000326 | BDT33 | BIOLIGHT DUAL REAMER #3 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 32 | 00667147000319 | BDT32 | BIOLIGHT DUAL REAMER #2 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 33 | 00667147000296 | BDT25 | BIOLIGHT DUAL REAMER # 0.5 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 34 | 00667147000289 | BDT13 | BIOLIGHT DUAL REFILL #3 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 35 | 00667147000272 | BDT12 | BIOLIGHT DUAL REFILL #2 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 36 | 00667147000265 | BDT11 | BIOLIGHT DUAL REFILL #1 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 37 | 00667147000258 | BDT05 | BIOLIGHT DUAL REFILL #0.5 | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 38 | 00667147000128 | FF08014 | PINK UD FIBERS (2-150MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FIBER FORCE | |
| 39 | 00667147000111 | FF08011 | WHITE BRAIDED ROPE 2MM ( 2-150MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FIBER FORCE | |
| 40 | 00667147000104 | FF08004 | PINK MESH (2-53MMx80MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FIBER FORCE | |
| 41 | 00667147000098 | FF08002 | PINK BRAIDED ROPE 2MM (2-150MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FIBER FORCE | |
| 42 | 00667147000081 | FF08001 | PINK BRAIDED ROPE 1MM (2-150MM) | EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | FIBER FORCE | |
| 43 | 66714700001453 | BST50 | BIOLIGHT ST EPOXY-FREE FIBER POSTS INTRO KIT | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 44 | 66714700001439 | BST250 | BIOLIGHT ST REAMER 1.50 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 45 | 66714700001422 | BST235 | BIOLIGHT ST REAMER 1.35 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 46 | 66714700001415 | BST220 | BIOLIGHT ST REAMER 1.20 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 47 | 66714700001408 | BST200 | BIOLIGHT ST REAMER 1.00 MM | ELR | Post, Root Canal | 1 | BIOLIGHT | |
| 48 | 66714700001385 | BST150 | BIOLIGHT ST REFILL 1.50 MM | ELR | Post, Root Canal | BIOLIGHT | ||
| 49 | 66714700001378 | BST135 | BIOLIGHT ST REFILL 1.35 MM | ELR | Post, Root Canal | BIOLIGHT | ||
| 50 | 66714700001361 | BST120 | BIOLIGHT ST REFILL 1.20 MM | ELR | Post, Root Canal | BIOLIGHT |
| 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 |