Radiology Information Systems, Inc. PowerDR
by Radiology Information Systems, Inc.
Radiology Information Systems, Inc. PowerDR is a radiology information system application software (FDA Class II) made by Radiology Information Systems, Inc., cleared under FDA 510(k) K191504 on 16 Aug 2019 and listed in FDA GUDID since 1 Dec 2022 (UDI-DI 00860009490604), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860009490604 | Date1 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191504 | Date16 Aug 2019 | StatusActive |
Official records
- AccessGUDID record 00860009490604
- FDA 510(k) database K191504
Across registries
- FDA 510(k) K191504 decided 16 Aug 2019 Active
- FDA GUDID UDI-DI 00860009490604 listed 1 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K191504
- Listed FDA GUDID 00860009490604
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Radiology Information Systems, Inc.
- Generic name
- Radiology information system application software
- Model / reference
- PowerDR
- Primary DI / UDI-DI
- 00860009490604
- 510(k) Number
- FDA product code
- JAA, MQB
- GMDN term
- Radiology information system application software
- Device class
- Class II
- Regulation number
- 892.1650, 892.1680
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified).
- UNBRANDED 3644-04 by Advance Medical Designs, Inc.
- UNBRANDED 06-LK901 by Advance Medical Designs, Inc.
- AXIOM SIRESKOP SD by Siemens Medical Systems USA, Inc.
- PEGASUS LATERAL CARDIAC POSITIONER by Fischer Imaging Corp.
- FLUOROSPOT COMPACT by SIEMENS MEDICAL SOLUTIONS USA, INC.
- C-ARM CEILING CRANE FT-2 by Medicor USA, Ltd.
- DIGIFORMER HR DFP-50A by Toshiba America Medical Systems, In.C
- OrthoScan Mobile DI Mini C-arm 1000-0005 by Ziehm-Orthoscan, Inc.
- URETERAL COMPRESSION DEVICE by Bt Medical Co., Inc.
- SYMPHONY 360 REMOTE CONTROL TABLE by Acoma Medical Imaging, Inc.