No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B216P700MAC1 | P700M A/C | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
2 | B216MB715NT1 | MB-715NT | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
3 | B216LB715NT1 | LB-715NT | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
4 | B216HDRI715A401 | HDRI-715A-40 | TABLE TOP X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
5 | B216HDR715A401 | HDR-715A-40 | TABLE TOP X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
6 | B216FB910A40K1 | FB910A-40K | PODIATRY X-RAY MACHINE, 10mA, 50-90kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
7 | B216FB715NT1 | FB-715NT | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
8 | B216BDXC7001 | BDXC-700 | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
9 | B216715TBD1 | 715T-BD | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
10 | B216715SD1 | 715-SD | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
11 | B216715RSD1 | 715R-SD | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION | |
12 | B216715BBD1 | 715B-BD | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | KPR | System, X-Ray, Stationary | 2 | X-CEL X-RAY CORPORATION |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00810035220454 | 1 | Radmedix AcuityUDR | RADMEDIX, LLC | ||
2 | 00810035220423 | 1 | Radmedix AcuitySDR+ | RADMEDIX, LLC | ||
3 | 00810035220416 | 1 | Radmedix AcuitySDR | RADMEDIX, LLC | ||
4 | 00810035220409 | 1 | Radmedix AcuityCDR | RADMEDIX, LLC | ||
5 | 00810035220393 | 1 | Radmedix AcuityFDR+ | RADMEDIX, LLC | ||
6 | 00810035220386 | 1 | Radmedix AcuityFDR | RADMEDIX, LLC | ||
7 | 00810035220324 | Plus | AcuitySDR | RADMEDIX, LLC | ||
8 | 00810035220317 | Plus | AcuitySDR | RADMEDIX, LLC | ||
9 | 00810035220102 | AcuitySDR | Radmedix | RADMEDIX, LLC | ||
10 | 00810035220096 | AcuitySDR | Radmedix | RADMEDIX, LLC | ||
11 | 00810035220089 | AcuitySDR+ | Radmedix | RADMEDIX, LLC | ||
12 | 00810035220072 | AcuitySDR+ | Radmedix | RADMEDIX, LLC | ||
13 | 00810035220065 | AcuitySDR+ | Radmedix | RADMEDIX, LLC | ||
14 | 00810035220058 | Plus | AcuitySDR | RADMEDIX, LLC | ||
15 | 00810035220041 | Standard | AcuitySDR | RADMEDIX, LLC | ||
16 | 00810035220034 | Standard | AcuitySDR | RADMEDIX, LLC | ||
17 | 00810035220027 | Plus | AcuitySDR | RADMEDIX, LLC | ||
18 | 00810035220010 | Plus | AcuitySDR | RADMEDIX, LLC | ||
19 | 00810035220003 | Plus | AcuitySDR | RADMEDIX, LLC | ||
20 | 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 | |
21 | 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 | |
22 | 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 |
23 | 00195278118356 | Tempo | B2401CAB | Definium Tempo System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
24 | 00195278070265 | Tempo Pro | B2402CAB | Definium Tempo Pro System UDI | Definium | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
25 | B619X200 | XPERT 20 | specimen x-ray system | KUBTEC | KUBTEC | |
26 | B525ST120 | ST-12 | Velcro Strap for Ingot | OCTOSTOP INC | ||
27 | B525ST110 | ST-11 | Velcro Strap for Half Ingot | OCTOSTOP INC | ||
28 | B525ST050 | ST-05 | Velcro Strap for Ridges | OCTOSTOP INC | ||
29 | B525ST030 | ST-03 | Velcro Strap For Prism | OCTOSTOP INC | ||
30 | B525FIKIT0 | FI-KIT | FI-Kit | OCTOSTOP INC | ||
31 | B525FI100 | FI-10 | Internal Rotation Ridges | OCTOSTOP INC | ||
32 | B525FI09C0 | FI-09C | External Right | OCTOSTOP INC | ||
33 | B525FI09B0 | FI-09B | Main Inter-Leg Filter | OCTOSTOP INC | ||
34 | B525FI09A0 | FI-09A | Inter-Thigh Filter | OCTOSTOP INC | ||
35 | B525FI090 | FI-09 | Ridges Plus | OCTOSTOP INC | ||
36 | B525FI060 | FI-06 | Boomerang 15 Degre | OCTOSTOP INC | ||
37 | B525FI04A0 | FI-04A | Little Prism | OCTOSTOP INC | ||
38 | B525FI040 | FI-04 | Prism | OCTOSTOP INC | ||
39 | B525FI03A0 | FI-03A | Half Gentle Slope | OCTOSTOP INC | ||
40 | B525FI030 | FI-03 | Gentle Slope | OCTOSTOP INC | ||
41 | B525FI02A0 | FI-02A | Half Ingot | OCTOSTOP INC | ||
42 | B525FI020 | FI-02 | Ingot | OCTOSTOP INC | ||
43 | B525FI01NC0 | FI-01NC | Boomerang no Chain | OCTOSTOP INC | ||
44 | B525FI01A0 | FI-01A | Boomerang with Velcro | OCTOSTOP INC | ||
45 | B525FI010 | FI-01 | Boomerang | OCTOSTOP INC | ||
46 | B269SWR00069MD0 | SWR-00069-MD | CuattroDR System Software | CuattroDR | CUATTRO MEDICAL | |
47 | B216P700MAC1 | P700M A/C | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
48 | B216MB715NT1 | MB-715NT | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
49 | B216LB715NT1 | LB-715NT | PODIATRY X-RAY MACHINE, 15mA, 50-70kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. | |
50 | B216HF718BD1 | HF 718BD | PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV | X-CEL X-RAY CORPORATION | ARQUILLA, INC. |