RoseM RSM 1824C
by Drtech Corp.
RoseM RSM 1824C is a Class II device made by Drtech Corp., cleared under FDA 510(k) K162670 on 23 Feb 2017 and listed in FDA GUDID since 4 Aug 2017 (UDI-DI 08800018401606), active as of 23 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 | Number08800018401606 | Date4 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162670 | Date23 Feb 2017 | StatusActive |
Official records
- AccessGUDID record 08800018401606
- FDA 510(k) database K162670
Across registries
- FDA 510(k) K162670 decided 23 Feb 2017 Active
- FDA GUDID UDI-DI 08800018401606 listed 4 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K162670
- Listed FDA GUDID 08800018401606
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RoseM
- Generic name
- Indirect flat panel x-ray detector
- Model / reference
- RSM 1824C
- Primary DI / UDI-DI
- 08800018401606
- 510(k) Number
- FDA product code
- MUE
- GMDN term
- Indirect flat panel x-ray detector
- Device class
- Class II
- Regulation number
- 892.1715
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Indirect flat panel x-ray detector.