PowerDR
by Radiology Information Systems, Inc.
510(k) K191504
PowerDR is a medical device (FDA Class II; FDA product code JAA, System, X-Ray, Fluoroscopic, Image-Intensified) made by Radiology Information Systems, Inc., cleared under FDA 510(k) K191504 on 16 Aug 2019, 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 | FDA 510(k)SESE | NumberK191504 | Date16 Aug 2019 | StatusActive |
Official records
- FDA 510(k) database K191504
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAA
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191504
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Radiology Information Systems, Inc. PowerDR | PowerDR | 00860009490604 | — | On the market |
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