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MinXray TR90BH

by Minxray, Inc.

MinXray TR90BH is a Class II device made by Minxray, Inc., cleared under FDA 510(k) K182207 on 14 Dec 2018 and listed in FDA GUDID since 14 Jan 2019 (UDI-DI 00858846007253), 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) K182207

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 Number00858846007253 UDI-DI Date14 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182207 Date14 Dec 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182207 decided 14 Dec 2018 Active
  • FDA GUDID UDI-DI 00858846007253 listed 14 Jan 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182207
  2. Listed FDA GUDID 00858846007253

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MinXray
Generic name
Portable basic diagnostic x-ray system, analogue
Model / reference
TR90BH
Primary DI / UDI-DI
00858846007253
510(k) Number
FDA product code
IZL
GMDN term
Portable basic diagnostic x-ray system, analogue
Device class
Class II
Regulation number
892.1720
GUDID distribution status
In Commercial Distribution

Related devices

Category: Portable basic diagnostic x-ray system, analogue

Similar devices

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

Other devices from Minxray, Inc.

See all devices from Minxray, Inc. →

Properties

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