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Monarch RT 202

by Meridian Medical Systems, LLC

Monarch RT 202 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 00851354007012), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K140251

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851354007012 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140251 Date22 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140251 decided 22 Oct 2014 Active
  • FDA GUDID UDI-DI 00851354007012 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140251
  2. Listed FDA GUDID 00851354007012

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Monarch
Generic name
Flat panel x-ray detector integration unit
Model / reference
RT 202
Primary DI / UDI-DI
00851354007012
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

Related devices

Category: Flat panel x-ray detector integration unit

Cleared under the same submission (K140251)

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Other devices from Meridian Medical Systems, LLC

See all devices from Meridian Medical Systems, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)