Monarch RT 204
by Meridian Medical Systems, LLC
Monarch RT 204 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 00851354007036), 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 | Number00851354007036 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140251 | Date22 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 00851354007036
- FDA 510(k) database K140251
Across registries
- FDA 510(k) K140251 decided 22 Oct 2014 Active
- FDA GUDID UDI-DI 00851354007036 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K140251
- Listed FDA GUDID 00851354007036
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- Withdrawn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 204
- Primary DI / UDI-DI
- 00851354007036
- 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
Similar devices
Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).
- FDR D-EVOIII Battery Pack S DR1800 SE BATTERY S E by FUJIFILM CORPORATION
- ADD by H&abyz Co., Ltd.
- KONICA DIRECT DIGITIZER REGIUS, MODEL 170 by Konica Minolta Medical & Graphic, Inc.
- PHILIPS BUCKY VISION by Philips Medical Systems
- AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS by Agfa Healthcare Corp.
- FLAATZ 750 by Drtech Corp.
- WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR by Fujifilm Medical System U.S.A., Inc.
- VIVIX-S 4386W (FXRD-4386WA) by VIEWORKS CO., LTD.
- PCCR DIGITAL IMAGING DEVICE by Orex Computed Radiography, Ltd.
- PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector by Perkinelmer, Inc.