No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840682145978 | GCMWS-C5 | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | ||
2 | 00840682140942 | 5765282 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
3 | 00840682146555 | 5835165 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | NA | ||
4 | 00840682141932 | 6788888-2 | IXQ,IZZ | Table, radiographic, stationary top,Table, radiographic, non-tilting, powered | 2 | NA | ||
5 | 00840682141895 | 5786623 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
6 | 00840682138932 | 5794807 | CCX | SUPPORT, PATIENT POSITION | 1 | NA | ||
7 | 00840682138925 | B2100BLT | CCX | SUPPORT, PATIENT POSITION | 1 | NA | ||
8 | 00840682125871 | 5896002 | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | ||
9 | 00840682125864 | 9999966 | IXQ | Table, radiographic, stationary top | 2 | NA | ||
10 | 00840682125857 | 5896000 | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | ||
11 | 00840682123839 | 6788888 | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | NA | ||
12 | 00840682118583 | EXPRESS COIL - POSTERIOR ARRAY | LNI,LNH | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | NA | ||
13 | 00840682118033 | 5455274-100 | G8336LL | LNH | System, nuclear magnetic resonance imaging | 2 | NA | |
14 | 00840682117906 | 6999999 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
15 | 00840682116794 | 54576659-100 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
16 | 00840682106504 | 4265300 | MOS,LNH | Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging | 2 | NA | ||
17 | 00840682103572 | 5121647-4 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
18 | 00840682102674 | 5380966 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
19 | 00195278569813 | 5135678-9 | BB X-RAY OVERHEAD TUBE SUSPENSION | IYB | Tube mount, x-ray, diagnostic | 1 | NA | |
20 | 00195278569745 | 5135678-10 | BB X-RAY OVERHEAD TUBE SUSPENSION | IYB | Tube mount, x-ray, diagnostic | 1 | NA | |
21 | 00195278527455 | 9999666 | 9999666 | Bamboo RAD Elevation Table | IZZ | Table, radiographic, non-tilting, powered | 2 | NA |
22 | 00195278363947 | 1.0 | MaxFOV 2 Application Container for Smart Subscription | JAK | System, x-ray, tomography, computed | 2 | MaxFOV 2 | |
23 | 00195278012258 | 6788888-3 | G4 Table HLA | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | |
24 | 00195278011022 | 5842636 | G4 Non-Tilting Wallstand | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | |
25 | 00840682117869 | 5376496-15 | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Brivo 615 | ||
26 | 00840682154338 | H2401DS | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | D630 to D670 DR Upgrade | ||
27 | 00840682120777 | XRa | PDU COMPONENT ASSEMBLE | KPR | System, x-ray, stationary | 2 | Proteus | |
28 | 00840682145541 | One CFD | OWB,JAA,OXO | Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | ||
29 | 00840682147392 | Maxima US | Revolution Maxima CT designated medical device, WSO make | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
30 | 00840682146197 | ACT LMB | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
31 | 00840682146180 | Maxima | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
32 | 00840682146159 | Ace | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
33 | 00840682137553 | Frontier | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
34 | 00840682135313 | ACT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
35 | 00840682125604 | One | OWB,OXO,JAA | Interventional fluoroscopic x-ray system,Image-intensified fluoroscopic x-ray sy Interventional fluoroscopic x-ray system,Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, image-intensified | 2 | OEC | ||
36 | 00840682118835 | Elite MiniView | OXO,JAA | Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, image-intensified | 2 | OEC | ||
37 | 00840682115438 | Brivo Essential | OXO,JAA | Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, image-intensified | 2 | OEC | ||
38 | 00840682115377 | Brivo Plus | JAA,OXO | System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x- System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | ||
39 | 00840682115360 | Brivo Prime | JAA,OXO | System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x- System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | ||
40 | 00840682106139 | WDR1 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | WIRELESS DR IMAGING OPTION | ||
41 | 00195278502582 | Elite MiniView | MEDICAL DEVICE, UDI LABEL PLACEMENT, MiniView | JAA,OXO | System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x- System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | |
42 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
43 | 00195278403087 | Eagle | Revolution Eagle designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
44 | 00195278385215 | Advance | Revolution Advance designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
45 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
46 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
47 | 00195278118356 | Tempo | B2401CAB | Definium Tempo System UDI | KPR,IZF,MQB | System, x-ray, stationary,System, x-ray, tomographic,Solid state x-ray imager (f System, x-ray, stationary,System, x-ray, tomographic,Solid state x-ray imager (flat panel/digital imager) | 2 | Definium |
48 | 00195278070265 | Tempo Pro | B2402CAB | Definium Tempo Pro System UDI | MQB,IZF,KPR | Solid state x-ray imager (flat panel/digital imager),System, x-ray, tomographic, Solid state x-ray imager (flat panel/digital imager),System, x-ray, tomographic,System, x-ray, stationary | 2 | Definium |
49 | 00840682146210 | XR656 | KPR | System, x-ray, stationary | 2 | Discovery | ||
50 | 00840682138598 | XR656 HD | KPR,MQB,IZF | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager),S System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager),System, x-ray, tomographic | 2 | Discovery |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B225100000170 | 1000-0017 | Image-Intensified Fluoroscopic X-Ray, Mobile | TAU Model 1000-0017 Mini C-Arm | ORTHOSCAN, INC. | |
2 | B225100000160 | 1000-0016 | Image-Intensified Fluoroscopic X-Ray System, Mobile | TAU Model 1000-0016 Mini C-Arm | ORTHOSCAN, INC. | |
3 | B225100000150 | 1000-0015 | Image-Intensified Fluoroscopic X-Ray System, Mobile | TAU Model 1000-0015 Mini C-Arm | ORTHOSCAN, INC. | |
4 | B225100000050 | 1000-0005 | Image-intensified fluoroscopic x-ray system, mobile | OrthoScan Mobile DI Mini C-arm | ORTHOSCAN, INC. | |
5 | B225100000040 | 1000-0004 | Image-intensified fluoroscopic x-ray system, mobile | OrthoScan HD Mini C-arm | ORTHOSCAN, INC. | |
6 | B209CAS2X10 | 2.1 | V3D-Calcium Scoring is a software application used with advanced PC hardware for V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent. | V3D-Calcium Scoring | VIATRONIX INCORPORATED | |
7 | B209CAS2X00 | 2.0 | V3D-Calcium Scoring is a software application used with advanced PC hardware for V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent. | V3D-Calcium Scoring | VIATRONIX INCORPORATED | |
8 | B209CAR1X10 | 1.1 | V3D-Cardiac is a software application used with advanced PC hardware for evaluat V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomalies based on contrast enhanced CT images. It provides both coronary artery tracking and left ventricle volume analyzing tools for single or multi-phase CT scan. | V3D-Cardiac | VIATRONIX INCORPORATED | |
9 | B201CGSCENERGY0 | CGSCENERGY | Clear Guide SCENERGY | CLEAR GUIDE MEDICAL, INC. | ||
10 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
11 | B201CGCORE24MR0 | CGCORE24MR | CG-CORE24-MR | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
12 | B201CGCORE240 | CGCORE24 | CG-CORE24 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
13 | B201CGCORE130 | CGCORE13 | CG-CORE-13 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
14 | 86000594161101 | 9801101000 | 86000594161101 | SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquir SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head includingthe ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ),other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use indiagnostic support. The device displays two and three dimensional images for each examined anatomical region.The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | SeeFactor CT3 | EPICA MEDICAL INNOVATIONS LLC |
15 | 60889971743572 | OnSight 3D Extremity System | 1743574 | ONSIGHT 3D EXTREMITY SYS W RMT CONSOLE | OnSight 3D Extremity System | CARESTREAM HEALTH, INC. |
16 | 60889971743565 | OnSight 3D Extremity System | 1743566 | ONSIGHT 3D EXTREMITY SYS W ATCH CONSOLE | OnSight 3D Extremity System | CARESTREAM HEALTH, INC. |
17 | 47630039301444 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System 1731 ed03 | BRACCO INJENEERING SA | |
18 | 47630039301437 | 017285 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
19 | 47630039301000 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA | |
20 | 47630039300904 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300891 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
21 | 47630039300812 | 017383 | 017383 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822 | EmpowerCTA®+ Injector System with EDA | BRACCO INJENEERING SA |
22 | 47630039300782 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
23 | 47630039300447 | 017383 | 017383 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393004881 x Injector GTIN : 37630039300747 | EmpowerCTA®+ Injector System with EDA | BRACCO INJENEERING SA |
24 | 47630039300430 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393004881 x Injector GTIN : 37630039300747 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
25 | 37630039301812 | 017418 | 017418 | Injector Mounting Arm, Right | BRACCO INJENEERING SA | |
26 | 37630039301805 | 017417 | 017417 | Injector Mounting Arm, Left | BRACCO INJENEERING SA | |
27 | 37630039301737 | 015781 | EDA Clip | BRACCO INJENEERING SA | ||
28 | 37630039300709 | 017411 | 017411 | Floor Stand Shroud | BRACCO INJENEERING SA | |
29 | 37630039300693 | 017410 | 017410 | Floor Stand | BRACCO INJENEERING SA | |
30 | 37630039300686 | 015781 | 015781 | EDA Clip | BRACCO INJENEERING SA | |
31 | 37630039300679 | 017415 | 017415 | Ceiling Column Short | BRACCO INJENEERING SA | |
32 | 37630039300662 | 017414 | 017414 | Ceiling Column Medium | BRACCO INJENEERING SA | |
33 | 37630039300655 | 017413 | Ceiling Column Long | BRACCO INJENEERING SA | ||
34 | 37630039300648 | 017419 | 017419 | Ceiling Mount Adapter Plate | BRACCO INJENEERING SA | |
35 | 37630039300631 | 017418 | 017418 | Injector Mounting Arm, Right | BRACCO INJENEERING SA | |
36 | 37630039300624 | 017417 | 017417 | Injector Mounting Arm, Left | BRACCO INJENEERING SA | |
37 | 37630039300617 | 017416 | 017416 | Articulating arm | BRACCO INJENEERING SA | |
38 | 37630039300600 | 017528 | 017528 | IV pole | BRACCO INJENEERING SA | |
39 | 37630039300594 | 017527 | 017527 | Power Supply to remote USB cable | BRACCO INJENEERING SA | |
40 | 37630039300587 | 017526 | 017526 | EmpowerSync® Remote Control Pendant Switch | BRACCO INJENEERING SA | |
41 | 37630039300570 | 017524 | 017524 | Pendant Cable | BRACCO INJENEERING SA | |
42 | 37630039300563 | 017983 | 017983 | Power/Comm Cable (60’ Plenum) | BRACCO INJENEERING SA | |
43 | 37630039300556 | 017422 | 017422 | Power/Comm Cable (60’) | BRACCO INJENEERING SA | |
44 | 37630039300549 | 017523 | 017523 | EmpowerSync® Philips Scanner Interface Adapter | BRACCO INJENEERING SA | |
45 | 37630039300532 | 017613 | 017613 | Philips Scanner Cable | BRACCO INJENEERING SA | |
46 | 37630039300525 | 017521 | 017521 | Philips Brilliance Interconnect Cable | BRACCO INJENEERING SA | |
47 | 37630039300518 | 017421 | 017421 | Interconnect Power/Comm Cable (20') | BRACCO INJENEERING SA | |
48 | 37630039300501 | 017412 | 017412 | Power/Comm Cable (75') | BRACCO INJENEERING SA | |
49 | 37630039300495 | 017355 | 017355 | EmpowerSync® Cables | BRACCO INJENEERING SA | |
50 | SHZ03502022 | SHZ-035-020-22 | SHZ-035-020-22 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle. | VISICOIL MR | RADIOMED CORP |