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Paragon 2 RT312

by Meridian Medical Systems, LLC

Paragon 2 RT312, a mobile basic diagnostic x-ray system (FDA Class II) made by Meridian Medical Systems, LLC, was cleared under FDA 510(k) K162687 on 21 Oct 2016 and listed in FDA GUDID on 3 Nov 2017 (UDI-DI 00851354007159); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K162687

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 Number00851354007159 UDI-DI Date3 Nov 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162687 Date21 Oct 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162687 decided 21 Oct 2016 Active
  • FDA GUDID UDI-DI 00851354007159 listed 3 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162687
  2. Listed FDA GUDID 00851354007159

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Paragon 2
Generic name
Mobile basic diagnostic x-ray system, digital
Model / reference
RT312
Primary DI / UDI-DI
00851354007159
510(k) Number
FDA product code
MQB, IZL
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class II
Regulation number
892.1680, 892.1720
GUDID distribution status
Not in Commercial Distribution

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)