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Drgem Radmax

by DRGEM Corporation

Drgem Radmax is a Class II device made by DRGEM Corporation, cleared under FDA 510(k) K182537 on 8 Mar 2019 and listed in FDA GUDID since 12 Mar 2019 (UDI-DI 08800011170004), active as of 23 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 23 Oct 2026

Documents

510(k) K182537

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800011170004 UDI-DI Date12 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182537 Date8 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182537 decided 8 Mar 2019 Active
  • FDA GUDID UDI-DI 08800011170004 listed 12 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182537
  2. Listed FDA GUDID 08800011170004

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Drgem
Generic name
Basic x-ray clinical assessment support software
Model / reference
RADMAX
Primary DI / UDI-DI
08800011170004
510(k) Number
FDA product code
LLZ
GMDN term
Basic x-ray clinical assessment support software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic diagnostic x-ray system application software

Similar devices in this category

Other devices filed under Basic diagnostic x-ray system application software.

Other devices from DRGEM Corporation

See all devices from DRGEM Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)