No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 60889978869848 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 8869844 | 24X30CM CR MAMMO SCR EHR-M3 | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen |
2 | 60889978806324 | MIN-R 2 Cassette with MIN-R EV 190 Screen | 8806325 | 24X30CM MIN-R2 CASS W/EV 190 SCR | EAM,IXA | Screen, intensifying, radiographic,Cassette, radiographic film | 1 | MIN-R 2 Cassette with MIN-R EV 190 Screen |
3 | 60889978712878 | READYMATIC Fixer and Replenisher | 8712879 | READYMATIC Fixer and Repl - 4x1GL | IWZ | Film, radiographic | 1 | READYMATIC Fixer and Replenisher |
4 | 60889978622795 | CARESTREAM DRX-1 System | 8622797 | CARESTREAM DRX-1 SYSTEM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CARESTREAM DRX-1 System |
5 | 60889978621668 | Value Systems | 8621666 | GENERATOR GRP D 50KW 3P 208-240 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
6 | 60889978621651 | Value Systems | 8621658 | GENERATOR GRP C 50KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
7 | 60889978615209 | DRX Plus 2530C Detector | 8615205 | DRX PLUS 2530C DETECTOR/ ASCEND | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DRX Plus 2530C Detector |
8 | 60889978611614 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8611618 | 24X30CM DV REPLCMT PLATE/EHR-M2 SCR | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
9 | 60889978607587 | 4343R Digital Image Receptor | 8607582 | GOS Scintillator 4343 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
10 | 60889978602773 | DRX-Evolution Plus System | 8602773 | FIBRE GRID DRX-EVO WALL 180CM10:1 40LPCM | KPR | System, x-ray, stationary | 2 | DRX-Evolution Plus System |
11 | 60889978463329 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8463325 | 18X24CM DV REPLCMT PLATE/EHR-M2 SCR | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
12 | 60889978359158 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8359150 | 24X30CM DVIEW CR MAMMO SCR EHR-M2 | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
13 | 60889978346134 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8346132 | 24X30CM DVIEW CR MAMMO SCR EHR-M | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
14 | 60889978344062 | X-OMAT MX Developer and Replenisher | 8344061 | X-OMAT MX Developer and Repl 10 GL | IWZ | Film, radiographic | 1 | X-OMAT MX Developer and Replenisher |
15 | 60889978215201 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | 8215204 | 24X30 CR MAMMO CASS W/SNP-M1 SCREEN | MUE | Full field digital,system,x-ray,mammographic | 2 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen |
16 | 60889976701539 | Value Systems | 6701536 | GENERATOR GRP C 65KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
17 | 60889976701522 | Value Systems | 6701528 | GENERATOR GRP C 80KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
18 | 60889976701133 | TRIMAX 35C | 6701130 | TRIMAX 35C DETECTOR | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | TRIMAX 35C |
19 | 60889976579367 | Vita Flex CR System | 6579361 | VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
20 | 60889976579343 | Vita Flex CR System | 6579346 | VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
21 | 60889976573785 | LINEAR MC 150 | 6573786 | R40-M-R MANUAL COLLIMATOR FOR DR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
22 | 60889976573631 | QW-420-T | 6573638 | QW-420-T MOTORIZED TILT WALL STAND RT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
23 | 60889976573624 | QW-420-T | 6573620 | QW-420-T Motor Tilting Wall Stand (Left) | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
24 | 60889976573594 | QW-420-T | 6573596 | QW-420-MT Manual Tiltng WallStand (Left) | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
25 | 60889976573587 | QW-420-T | 6573588 | QW-420-MT Manual Tilting Wall Stand RT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
26 | 60889976573525 | QT-730 | 6573521 | QT-730 RADIOGRAPHC ENCLOSED STYL TABLE | IZZ | Table, radiographic, non-tilting, powered | 2 | QT-730 |
27 | 60889976573235 | QG-40-3 | 6573232 | QG-400-3 QUEST GEN 32KW 3 PH 380-480 | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-40-3 |
28 | 60889976567876 | CS 3500 3D Scanner Collar | 6567879 | CS3500 COLLAR PACKING (10 PIECES) | NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | CS 3500 3D Scanner Collar | |
29 | 60889976567166 | LINEAR MC 150 | 1015148 | R40-S-P PINNACLE MTRZD COLLIMATOR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
30 | 60889976567159 | LINEAR MC 150 | 1013309 | R40-M-P PROGENY MC150 MANUAL COLLIMATOR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
31 | 60889976566732 | CS 3500 3D Scanner Collar | 6566731 | CS3500 COLLAR PACKING (10 PIECES) | NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | 2 | CS 3500 3D Scanner Collar |
32 | 60889976559857 | CS 1500 | 6559850 | CS1500 HAND PIECE WIRELESS | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
33 | 60889976559819 | CS 1500 | 6559819 | CS1500 INTRA ORAL CAMERA WIRED USB | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
34 | 60889976559802 | CS 1500 | 6559801 | CS1500 INTRA ORAL CAMERA WIRELESS | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
35 | 60889976041376 | Green X-ray Film WB | 6041370 | 25SH 14X36IN (FLAT) GREEN X-RAY WB | IWZ | Film, radiographic | Green X-ray Film WB | |
36 | 60889975950419 | DRX Plus 2530C Detector | AH9482 | PACKED, DETECTOR, 2530 C | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DRX Plus 2530C Detector |
37 | 60889975313580 | CS 8100 Access | 5313580 | CS 8100 ACCESS | MUH | System,x-ray,extraoral source,digital | 2 | CS 8100 Access |
38 | 60889975303062 | CS 8100 Access | 5303060 | CS 8100 ACCESS 110V 230V | MUH | System,x-ray,extraoral source,digital | 2 | CS 8100 Access |
39 | 60889975285931 | READYMATIC Fixer and Replenisher | 5285937 | READYMATIC FIXER AND REPL, 2X5L | IWZ | Film, radiographic | 1 | READYMATIC Fixer and Replenisher |
40 | 60889975284484 | X-OMAT LE+ Fixer and Replenisher | 5284484 | X-OMAT LE+ FIXER AND REPL 2X20L | IWZ | Film, radiographic | 1 | X-OMAT LE+ Fixer and Replenisher |
41 | 60889975211015 | CEPHALOSTAT | 5211016 | CEPH UPGRADE FOR 9X00 FAMILY | MUH,OAS | System,x-ray,extraoral source,digital,X-ray, tomography, computed, dental | 2 | CEPHALOSTAT |
42 | 60889975154237 | CG797 | 5154232 | SIZE A COLLIMAT. FOR I/O XRAY UNITS | EHD | UNIT, X-RAY, EXTRAORAL WITH TIMER | 2 | CG797 |
43 | 60889974160215 | DETECTOR,PACKED,TRIMAX,4343C | AE4205 | AY-DETECTOR, PACKED, 4343C, TRIMAX | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | TRIMAX 4343C Detector |
44 | 60889974007909 | CS 1600 | 9G1174 | Handpiece, Wired, 1600 | NBL | Laser,fluorescence caries detection | 2 | CS 1600 |
45 | 60889974007473 | 4343R Digital Image Receptor | 9G9998 | 43X43 GOS DETECTOR | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
46 | 60889974007466 | 4343R Digital Image Receptor | 9G5716 | DRX-DETECTOR 43X43 CSI FIXED | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
47 | 60889974001112 | QG-50-SE | 1015247 | QG-5000-4 ODYSSEY SE GEN 50KW | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-50-SE |
48 | 60889974000979 | QG-40-3 | 1023290 | QG-40-3 X-RAY GEN 40KW 3 PHASE 380-480 | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-40-3 |
49 | 60889974000696 | QW-420 | 1018811 | QW-420 VERTI-Q-VERTICAL WALLSTAND LEFT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420 |
50 | 60889974000542 | QG-80 | 1015288 | QGV-80 Q-VISION GEN 80KW | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-80 |
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 | 00195278118356 | Tempo | B2401CAB | Definium Tempo System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
3 | 00195278070265 | Tempo Pro | B2402CAB | Definium Tempo Pro System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
4 | 00195278003348 | Navigate | AMX Navigate Designated Medical Device Assembly | AMX | GE MEDICAL SYSTEMS, INC. | |
5 | 00195174039687 | 17HQ901G-BP | LG | LG ELECTRONICS INC. | ||
6 | 00195174039663 | 14HQ901G-BP | LG | LG ELECTRONICS INC. | ||
7 | 00195174039496 | 10HQ701G-BP | LG | LG ELECTRONICS INC. | ||
8 | 00195174039472 | 17HQ701G-BP | LG | LG ELECTRONICS INC. | ||
9 | 00195174039458 | 14HQ701G-BP | LG | LG ELECTRONICS INC. | ||
10 | 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. | |
11 | 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. | |
12 | 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. | |
13 | 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. | |
14 | 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. | |
15 | B225100000170 | 1000-0017 | Image-Intensified Fluoroscopic X-Ray, Mobile | TAU Model 1000-0017 Mini C-Arm | ORTHOSCAN, INC. | |
16 | B225100000160 | 1000-0016 | Image-Intensified Fluoroscopic X-Ray System, Mobile | TAU Model 1000-0016 Mini C-Arm | ORTHOSCAN, INC. | |
17 | B225100000150 | 1000-0015 | Image-Intensified Fluoroscopic X-Ray System, Mobile | TAU Model 1000-0015 Mini C-Arm | ORTHOSCAN, INC. | |
18 | B22510000004FD0 | 1000-0004-FD | Image-intensified fluoroscopic x-ray system, mobile | OrthoScan Pulse Mini C-arm | ORTHOSCAN, INC. | |
19 | 60889978981311 | Elite CR System | 8981318 | Elite CR System W/WP | Elite CR System | CARESTREAM HEALTH, INC. |
20 | 60889978623280 | Lux Detector | 8623282 | LUX 35 DETECTOR /RETROFIT | Lux Detector | CARESTREAM HEALTH, INC. |
21 | 60889978622795 | CARESTREAM DRX-1 System | 8622797 | CARESTREAM DRX-1 SYSTEM | CARESTREAM DRX-1 System | CARESTREAM HEALTH, INC. |
22 | 60889978622382 | Focus Detector | 8622383 | FOCUS 35C DETECTOR FOR ROOM SYSTEMS/WP | Focus Detector | CARESTREAM HEALTH, INC. |
23 | 60889978619986 | DRX-Transportable System | 8619983 | DRX-TRANSPORTABLE SYSTEM/LITE | DRX-Transportable System | CARESTREAM HEALTH, INC. |
24 | 60889978618149 | DRX Plus 2530 C Detector | 8618142 | DRX2530C DETECTOR /RETROFITS | DRX Plus 2530 C Detector | CARESTREAM HEALTH, INC. |
25 | 60889978618132 | DRX Plus 2530 C Detector | 8618134 | DRX2530C DETECTOR /MOBILE | DRX Plus 2530 C Detector | CARESTREAM HEALTH, INC. |
26 | 60889978615247 | DRX Plus 2530 C Detector | 8615247 | DRX PLUS 2530C DETECTOR/ MOBILE | DRX Plus 2530 C Detector | CARESTREAM HEALTH, INC. |
27 | 60889978615209 | DRX Plus 2530C Detector | 8615205 | DRX PLUS 2530C DETECTOR/ ASCEND | DRX Plus 2530C Detector | CARESTREAM HEALTH, INC. |
28 | 60889978615179 | DRX Plus 2530 C Detector | 8615171 | DRX PLUS 2530C DETECTOR/ EVOLUTION | DRX Plus 2530 C Detector | CARESTREAM HEALTH, INC. |
29 | 60889978615148 | DRX Plus 2530 C Detector | 8615148 | DRX PLUS 2530C DETECTOR/ RETROFIT | DRX Plus 2530 C Detector | CARESTREAM HEALTH, INC. |
30 | 60889978607587 | 4343R Digital Image Receptor | 8607582 | GOS Scintillator 4343 CM | 4343R Digital Image Receptor | CARESTREAM HEALTH, INC. |
31 | 60889978604784 | DRX-Transportable System | 8604787 | DRX-TRANSPORTABLE SYSTEM /LITE | DRX-Transportable System | CARESTREAM HEALTH, INC. |
32 | 60889978113613 | Classic CR System | 8113615 | Classic CR System | Classic CR System | CARESTREAM HEALTH, INC. |
33 | 60889978002740 | VITA CR LONG LENGTH IMAGING SYSTEM | 8002743 | VITA CR LLI SYS FIELD INSTALLED | VITA CR LONG LENGTH IMAGING SYSTEM | CARESTREAM HEALTH, INC. |
34 | 60889978002535 | Vita CR System | 8002537 | VITA CR FOR IDEXX | Vita CR System | CARESTREAM HEALTH, INC. |
35 | 60889978002528 | Vita CR System | 8002529 | VITA CR SYSTEM | Vita CR System | CARESTREAM HEALTH, INC. |
36 | 60889976702345 | TRIMAX 43C | 6702344 | TRIMAX 43C DETECTOR | TRIMAX 43C | CARESTREAM HEALTH, INC. |
37 | 60889976702338 | Focus 43C Detector | 6702336 | FOCUS 43C DETECTOR/RETROFIT | Focus 43C Detector | CARESTREAM HEALTH, INC. |
38 | 60889976701133 | TRIMAX 35C | 6701130 | TRIMAX 35C DETECTOR | TRIMAX 35C | CARESTREAM HEALTH, INC. |
39 | 60889976701126 | Focus 35C Detector | 6701122 | CARESTREAM FOCUS 35C DETECTOR/RETROFIT | Focus 35C Detector | CARESTREAM HEALTH, INC. |
40 | 60889976579367 | Vita Flex CR System | 6579361 | VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO | Vita Flex CR System | CARESTREAM HEALTH, INC. |
41 | 60889976579343 | Vita Flex CR System | 6579346 | VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO | Vita Flex CR System | CARESTREAM HEALTH, INC. |
42 | 60889976579336 | Vita Flex CR System | 6579338 | VITA FLEX CR SYSTEM 60PPH | Vita Flex CR System | CARESTREAM HEALTH, INC. |
43 | 60889975950570 | Lux 35 Detector | AK7294 | PACKED, LUX 35 DETECTOR, 3543 | Lux 35 Detector | CARESTREAM HEALTH, INC. |
44 | 60889975950563 | DRX Plus 4343C DETECTOR | AL6764 | PACKED, 4343C DETECTOR, DRX PLUS | DRX Plus 4343C DETECTOR | CARESTREAM HEALTH, INC. |
45 | 60889975950556 | DRX Plus 4343 DETECTOR | AL6759 | PACKED, 4343 DETECTOR, DRX PLUS | DRX Plus 4343 DETECTOR | CARESTREAM HEALTH, INC. |
46 | 60889975950549 | DRX Plus 3543C Detector | AL6755 | PACKED, 3543C DETECTOR, DRX PLUS | DRX Plus 3543C Detector | CARESTREAM HEALTH, INC. |
47 | 60889975950532 | DRX Plus 3543 Detector | AL6750 | PACKED, 3543 DETECTOR, DRX PLUS | DRX Plus 3543 Detector | CARESTREAM HEALTH, INC. |
48 | 60889975950525 | DRX 2530C Detector | AG4322 | PACKED, 2530C DETECTOR, DRX CORE 2 | DRX 2530C Detector | CARESTREAM HEALTH, INC. |
49 | 60889975950419 | DRX Plus 2530C Detector | AH9482 | PACKED, DETECTOR, 2530 C | DRX Plus 2530C Detector | CARESTREAM HEALTH, INC. |
50 | 60889974160239 | DETECTOR,PACKED,TRIMAX,4343FC | AE4207 | AY-DETECTOR, PACKED, 4343FC, TRIMAX | TRIMAX 4343FC Detector | CARESTREAM HEALTH, INC. |