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 | 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 | ||
28 | 00840682147392 | Maxima US | Revolution Maxima CT designated medical device, WSO make | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
29 | 00840682146197 | ACT LMB | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
30 | 00840682146180 | Maxima | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
31 | 00840682146159 | Ace | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
32 | 00840682137553 | Frontier | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
33 | 00840682135313 | ACT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
34 | 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 | ||
35 | 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 | ||
36 | 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 | ||
37 | 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 | ||
38 | 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 | ||
39 | 00840682106139 | WDR1 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | WIRELESS DR IMAGING OPTION | ||
40 | 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 | |
41 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
42 | 00195278403087 | Eagle | Revolution Eagle designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
43 | 00195278385215 | Advance | Revolution Advance designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
44 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
45 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
46 | 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 |
47 | 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 |
48 | 00840682146210 | XR656 | KPR | System, x-ray, stationary | 2 | Discovery | ||
49 | 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 | ||
50 | 00840682118699 | RT | Discovery RT designated medical device | JAK | System, x-ray, tomography, computed | 2 | Discovery |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817100020490 | OPAL 02-04-06-000 | Opal-RAD is a software device that receives digital images and data from various Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. | Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
2 | 00817100020339 | PAN262 | THL Flat Panel Detector-R | Flat Panel Detector | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
3 | 00817100020285 | PAN280 | THL 3543EZ CsI Digital Wireless Flat Panel Detector-R | 3543EZ CsI Digital Wireless Flat Panel Detector | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
4 | 00817100020209 | OPAL 02-04-04-000 | Opal-RAD is a software device that receives digital images and data from various Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. | Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
5 | 00817100020162 | XR1000i | 2020SA | 2020i Radiographic Straight Arm system variable focal distance left loading only | 2020i Straight Arm | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. |
6 | 00817100020155 | XR420i | HDR | Dedicated Hand X-Ray system | 2020i Imaging Hand System | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. |
7 | 00817100020148 | XR410i | PXS-710 | X-Ray System, Podiatry DR Ready (70kVp,10mA). | 2020 Imaging Podiatry System HF | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. |
8 | 00817100020131 | XR400i | BD715 | 20/20 BiDirectional PDR X-ray Machine. | 2020 Imaging Podiatry System | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. |
9 | 00817100020094 | XR5200 | NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touc NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions). | Overhead Tube Crane | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
10 | 00817100020070 | XR5100 | Manual ceiling suspension tube stand ONLY | Overhead Tube Crane Ceiling Suspension | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
11 | 00817100020063 | XR100 | Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Digital SID | Millenium Floor Mounted Tube Stand | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
12 | 00817100020056 | XR3500B | Advanced Universal U-arm Stand 4000 - Motorized Auto Positioning and Touchscreen control | Advanced Universal U-Arm Stand 4000 | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
13 | 00817100020049 | XR3002 | Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchs Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchscreen control | Advanced Universal U-Arm Stand 3000 | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
14 | 00817100020032 | XR3000 | Universal U-arm system - With Motorized Auto Positioning and Touchscreen control | U-Arm System | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
15 | 00817100020025 | XR3001 | Universal U-arm system - Motorized. | U-Arm System Basic | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
16 | 00817100020018 | XR1000 | Universal Radiographic Straight Arm system variable focal distance left loading Only. | Straight Arm System | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
17 | 00810035220454 | 1 | Radmedix AcuityUDR | RADMEDIX, LLC | ||
18 | 00810035220423 | 1 | Radmedix AcuitySDR+ | RADMEDIX, LLC | ||
19 | 00810035220416 | 1 | Radmedix AcuitySDR | RADMEDIX, LLC | ||
20 | 00810035220409 | 1 | Radmedix AcuityCDR | RADMEDIX, LLC | ||
21 | 00810035220393 | 1 | Radmedix AcuityFDR+ | RADMEDIX, LLC | ||
22 | 00810035220386 | 1 | Radmedix AcuityFDR | RADMEDIX, LLC | ||
23 | 00810035220324 | Plus | AcuitySDR | RADMEDIX, LLC | ||
24 | 00810035220317 | Plus | AcuitySDR | RADMEDIX, LLC | ||
25 | 00810035220102 | AcuitySDR | Radmedix | RADMEDIX, LLC | ||
26 | 00810035220096 | AcuitySDR | Radmedix | RADMEDIX, LLC | ||
27 | 00810035220089 | AcuitySDR+ | Radmedix | RADMEDIX, LLC | ||
28 | 00810035220072 | AcuitySDR+ | Radmedix | RADMEDIX, LLC | ||
29 | 00810035220065 | AcuitySDR+ | Radmedix | RADMEDIX, LLC | ||
30 | 00810035220058 | Plus | AcuitySDR | RADMEDIX, LLC | ||
31 | 00810035220041 | Standard | AcuitySDR | RADMEDIX, LLC | ||
32 | 00810035220034 | Standard | AcuitySDR | RADMEDIX, LLC | ||
33 | 00810035220027 | Plus | AcuitySDR | RADMEDIX, LLC | ||
34 | 00810035220010 | Plus | AcuitySDR | RADMEDIX, LLC | ||
35 | 00810035220003 | Plus | AcuitySDR | RADMEDIX, LLC | ||
36 | 00810030350071 | uDR 780i | The uDR 780i digital medical x-ray system is intended for use by a qualified/tra The uDR 780i digital medical x-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography. | uDR | UIH TECHNOLOGIES LLC | |
37 | 00810030350002 | uDr 596i | The uDR 596i Radiographic system is intended to be used by a qualified/trained d The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography. | uDR | UIH TECHNOLOGIES LLC | |
38 | 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 |
39 | 00195278118356 | Tempo | B2401CAB | Definium Tempo System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
40 | 00195278070265 | Tempo Pro | B2402CAB | Definium Tempo Pro System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
41 | B619X200 | XPERT 20 | specimen x-ray system | KUBTEC | KUBTEC | |
42 | B525ST120 | ST-12 | Velcro Strap for Ingot | OCTOSTOP INC | ||
43 | B525ST110 | ST-11 | Velcro Strap for Half Ingot | OCTOSTOP INC | ||
44 | B525ST050 | ST-05 | Velcro Strap for Ridges | OCTOSTOP INC | ||
45 | B525ST030 | ST-03 | Velcro Strap For Prism | OCTOSTOP INC | ||
46 | B525FIKIT0 | FI-KIT | FI-Kit | OCTOSTOP INC | ||
47 | B525FI100 | FI-10 | Internal Rotation Ridges | OCTOSTOP INC | ||
48 | B525FI09C0 | FI-09C | External Right | OCTOSTOP INC | ||
49 | B525FI09B0 | FI-09B | Main Inter-Leg Filter | OCTOSTOP INC | ||
50 | B525FI09A0 | FI-09A | Inter-Thigh Filter | OCTOSTOP INC |