No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840682144209 | 5777746 | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | NA | ||
2 | 00840682119658 | 5421698 | IZL | System, x-ray, mobile | 2 | NA | ||
3 | 00195278003348 | Navigate | AMX Navigate Designated Medical Device Assembly | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | AMX | |
4 | 00840682121071 | 4343 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
5 | 00840682120982 | 600FP | JAA | System, x-ray, fluoroscopic, image-intensified | 2 | Precision | ||
6 | 00840682120807 | 3543 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
7 | 00840682120784 | 2530 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
8 | 00840682119238 | 500D | JAA | System, x-ray, fluoroscopic, image-intensified | 2 | Precision | ||
9 | 00840682143974 | 5607000-2 | KPS | System, tomography, computed, emission | 2 | O560 to 610 Upgrade | ||
10 | 10840682142875 | 690 VCT Boost Upgrade | KPS | System, tomography, computed, emission | 2 | Discovery PET CT | ||
11 | 00840682116732 | 5340000-7 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FlashPad | ||
12 | 00840682116701 | 5340000-8 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FlashPad | ||
13 | 00840682125574 | Discovery CT A | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
14 | 00840682146616 | Apex | 5590000-20 | Revolution Apex - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
15 | 00840682146357 | OpenOC16 Console Upgrade | KPS | System, tomography, computed, emission | 2 | Discovery IQ | ||
16 | 00840682143981 | 5607000 | KPS | System, tomography, computed, emission | 2 | O560 to D600 Upgrade | ||
17 | 00840682143646 | CT with Apex edition | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
18 | 00840682142601 | 2 | JAK | System, x-ray, tomography, computed | 2 | SnapShot Freeze | ||
19 | 00840682140713 | CT with Quantix Upgrade | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
20 | 00840682138796 | 160mm Detector Upgrade | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
21 | 00840682123471 | CT ES | 5590000-15 | Revolution CT ES - Designated Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
22 | 00840682118552 | CT | 5590000-6 | Revolution CT - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
23 | 00840682104364 | 5000 | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | Definium | ||
24 | 00840682102490 | Discovery CT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
25 | 00195278454218 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Omni | |
26 | 00840682125703 | IQ 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
27 | 00840682103107 | IQ | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Discovery | ||
28 | 00840682146166 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
29 | 00840682143523 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
30 | 00840682120975 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
31 | 00840682108218 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
32 | 00840682103053 | PETCT 610 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
33 | 00840682102995 | PETCT 710 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
34 | 00195278098603 | MI | PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manuf PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Discovery | |
35 | 00840682146319 | with Apex edition | JAK | System, x-ray, tomography, computed | 2 | Revolution CT | ||
36 | 00840682141994 | 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery MI Columbird mE2 Application SW | ||
37 | 00840682123686 | XR240amx HD Upgrade | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima | ||
38 | 00840682142168 | XR646 HD Upgrade | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima | ||
39 | 00840682147316 | TS-RT-100 | TS-RT-100 | Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
40 | 00840682147309 | TS-RTW-100 | TS-RTW-100 | Replacement Tape Wide for TruSignal Wrap and Sensitive Skin sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
41 | 00840682147293 | TS-RWM-24 | TS-RWM-24 | Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
42 | 00840682147286 | TS-HB-3 | TS-HB-3 | Replacement Headband for TruSignal Ear sensor, 3 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
43 | 00840682147279 | TS-RWS-24 | TS-RWS-24 | Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
44 | 00840682147262 | TS-RTB-100 | TS-RTB-100 | Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
45 | 00840682147255 | TS-RWL-24 | TS-RWL-24 | Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
46 | 00840682147248 | TS-SND-3 | TS-SND-3 | Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
47 | 00840682147231 | PACS 1.0 | Designated Medical Device, Critical Care Suite PACS 1.0 | QFM | Radiological computer-assisted prioritization software for lesions | 2 | Critical Care Suite | |
48 | 00840682146340 | 1.0 | QFM,KPS | Radiological computer-assisted prioritization software for lesions,System, tomog Radiological computer-assisted prioritization software for lesions,System, tomography, computed, emission | 2 | Critical Care Suite | ||
49 | 00840682145749 | XR240amx HD Upgrade Gen2 | MQB,IZL | Solid state x-ray imager (flat panel/digital imager),System, x-ray, mobile | 2 | Optima | ||
50 | 00840682122351 | XR240amx | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00628451892021 | 1 | P008943 | The Halifax Imaging Kit is part of the SR Suite product line, provides an altern The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path tocreating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Raycomponents integrated into an existing digital radiography room already containing an FDAcleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kitand the existing DR system are synchronized by replacing the trigger switches of the twosystems with the Halifax Synchronization Switch. The Halifax Synchronization Switchensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray imagesfrom two different perspectives to be taken at the exact same time. This process allows forRoentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR).RSA is a stereo x-ray technique that enables measurements more accurate and precise thansingle plane radiography based on phantom studies. The increased level of precision enablesmeasurement of implant stability. | Halifax Imaging Kit | HALIFAX BIOMEDICAL INCORPORATED |
2 | 00628451892021 | 1 | P008943 | The Halifax Imaging Kit is part of the SR Suite product line, provides an altern The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path tocreating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Raycomponents integrated into an existing digital radiography room already containing an FDAcleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kitand the existing DR system are synchronized by replacing the trigger switches of the twosystems with the Halifax Synchronization Switch. The Halifax Synchronization Switchensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray imagesfrom two different perspectives to be taken at the exact same time. This process allows forRoentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR).RSA is a stereo x-ray technique that enables measurements more accurate and precise thansingle plane radiography based on phantom studies. The increased level of precision enablesmeasurement of implant stability. | Halifax Imaging Kit | HALIFAX BIOMEDICAL INCORPORATED |
3 | 00195278118356 | Tempo | B2401CAB | Definium Tempo System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
4 | 00195278118356 | Tempo | B2401CAB | Definium Tempo System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
5 | 00195278070265 | Tempo Pro | B2402CAB | Definium Tempo Pro System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
6 | 00195278070265 | Tempo Pro | B2402CAB | Definium Tempo Pro System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
7 | 00195278003348 | Navigate | AMX Navigate Designated Medical Device Assembly | AMX | GE MEDICAL SYSTEMS, INC. | |
8 | 00195174039687 | 17HQ901G-BP | LG | LG ELECTRONICS INC. | ||
9 | 00195174039663 | 14HQ901G-BP | LG | LG ELECTRONICS INC. | ||
10 | 00195174039496 | 10HQ701G-BP | LG | LG ELECTRONICS INC. | ||
11 | 00195174039472 | 17HQ701G-BP | LG | LG ELECTRONICS INC. | ||
12 | 00195174039458 | 14HQ701G-BP | LG | LG ELECTRONICS INC. | ||
13 | D678F38050 | F3805 | ScanX 12 SE is a device that scans photostimulable phosphor plates that have bee ScanX 12 SE is a device that scans photostimulable phosphor plates that have been exposed in the place of x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It is used as a podiatry unit. | ScanX 12 SE | AIR TECHNIQUES, INC. | |
14 | D678D5000QB0 | D5000QB | The ScanX D5000 series scanner is a device that reads photostimulable phosphor p The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display. | ScanX Quantum (with battery) | AIR TECHNIQUES, INC. | |
15 | D678D5000Q0 | D5000Q | The ScanX D5000 series scanner is a device that reads photostimulable phosphor p The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display. | ScanX Quantum (without battery) | AIR TECHNIQUES, INC. | |
16 | D678D5000FB0 | D5000FB | The ScanX D5000 series scanner is a device that reads photostimulable phosphor p The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display. | ScanX Fit (with battery) | AIR TECHNIQUES, INC. | |
17 | D678D5000F0 | D5000F | The ScanX D5000 series scanner is a device that reads photostimulable phosphor p The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display. | ScanX Fit (without battery) | AIR TECHNIQUES, INC. | |
18 | B619X200 | XPERT 20 | specimen x-ray system | KUBTEC | KUBTEC | |
19 | B525ST120 | ST-12 | Velcro Strap for Ingot | OCTOSTOP INC | ||
20 | B525ST110 | ST-11 | Velcro Strap for Half Ingot | OCTOSTOP INC | ||
21 | B525ST050 | ST-05 | Velcro Strap for Ridges | OCTOSTOP INC | ||
22 | B525ST030 | ST-03 | Velcro Strap For Prism | OCTOSTOP INC | ||
23 | B525FIKIT0 | FI-KIT | FI-Kit | OCTOSTOP INC | ||
24 | B525FI100 | FI-10 | Internal Rotation Ridges | OCTOSTOP INC | ||
25 | B525FI09C0 | FI-09C | External Right | OCTOSTOP INC | ||
26 | B525FI09B0 | FI-09B | Main Inter-Leg Filter | OCTOSTOP INC | ||
27 | B525FI09A0 | FI-09A | Inter-Thigh Filter | OCTOSTOP INC | ||
28 | B525FI090 | FI-09 | Ridges Plus | OCTOSTOP INC | ||
29 | B525FI060 | FI-06 | Boomerang 15 Degre | OCTOSTOP INC | ||
30 | B525FI04A0 | FI-04A | Little Prism | OCTOSTOP INC | ||
31 | B525FI040 | FI-04 | Prism | OCTOSTOP INC | ||
32 | B525FI03A0 | FI-03A | Half Gentle Slope | OCTOSTOP INC | ||
33 | B525FI030 | FI-03 | Gentle Slope | OCTOSTOP INC | ||
34 | B525FI02A0 | FI-02A | Half Ingot | OCTOSTOP INC | ||
35 | B525FI020 | FI-02 | Ingot | OCTOSTOP INC | ||
36 | B525FI01NC0 | FI-01NC | Boomerang no Chain | OCTOSTOP INC | ||
37 | B525FI01A0 | FI-01A | Boomerang with Velcro | OCTOSTOP INC | ||
38 | B525FI010 | FI-01 | Boomerang | OCTOSTOP INC | ||
39 | B269SWR00069MD0 | SWR-00069-MD | CuattroDR System Software | CuattroDR | CUATTRO MEDICAL | |
40 | B225100000170 | 1000-0017 | Image-Intensified Fluoroscopic X-Ray, Mobile | TAU Model 1000-0017 Mini C-Arm | ORTHOSCAN, INC. | |
41 | B225100000160 | 1000-0016 | Image-Intensified Fluoroscopic X-Ray System, Mobile | TAU Model 1000-0016 Mini C-Arm | ORTHOSCAN, INC. | |
42 | B225100000150 | 1000-0015 | Image-Intensified Fluoroscopic X-Ray System, Mobile | TAU Model 1000-0015 Mini C-Arm | ORTHOSCAN, INC. | |
43 | B22510000004FD0 | 1000-0004-FD | Image-intensified fluoroscopic x-ray system, mobile | OrthoScan Pulse Mini C-arm | ORTHOSCAN, INC. | |
44 | B216P700MAC1 | P700M A/C | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
45 | B216MB715NT1 | MB-715NT | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
46 | B216LB715NT1 | LB-715NT | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
47 | B216HF718BD1 | HF 718BD | PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
48 | B216HDRI715A401 | HDRI-715A-40 | TABLE TOP X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
49 | B216HDR715A401 | HDR-715A-40 | TABLE TOP X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
50 | B216FB910A40K1 | FB910A-40K | PODIATRY X-RAY MACHINE, 10mA, 50-90kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. |