Monarch RT 203
by Meridian Medical Systems, LLC
Monarch RT 203 is a Class II device made by Meridian Medical Systems, LLC, cleared under FDA 510(k) K140251 on 22 Oct 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00851354007029), 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 | Number00851354007029 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140251 | Date22 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 00851354007029
- FDA 510(k) database K140251
Across registries
- FDA 510(k) K140251 decided 22 Oct 2014 Active
- FDA GUDID UDI-DI 00851354007029 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140251
- Listed FDA GUDID 00851354007029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Monarch
- Generic name
- Flat panel x-ray detector integration unit
- Model / reference
- RT 203
- Primary DI / UDI-DI
- 00851354007029
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Flat panel x-ray detector integration unit
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
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