MinXray Integris

by Minxray, Inc.

MinXray Integris is a Class II device made by Minxray, Inc., cleared under FDA 510(k) K171353 on 7 Jun 2017 and listed in FDA GUDID since 4 Aug 2017 (UDI-DI 00858846007178), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00858846007178 UDI-DI	Date4 Aug 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK171353	Date7 Jun 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00858846007178
FDA 510(k) database 510(k) number K171353

Across registries

2 registries list this device

FDA 510(k) K171353 decided 7 Jun 2017 Active
FDA GUDID UDI-DI 00858846007178 listed 4 Aug 2017 Listed

Timeline

2 dated events

7 Jun 2017 Cleared FDA 510(k) K171353
4 Aug 2017 Listed FDA GUDID 00858846007178

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: MinXray
Generic name: Mobile basic diagnostic x-ray system, digital
Model / reference: Integris

Primary DI / UDI-DI: 00858846007178
510(k) Number: K171353
FDA product code: LLZ, MQB, IZL
GMDN term: Mobile basic diagnostic x-ray system, digital

Device class: Class II
Regulation number: 892.2050, 892.1680, 892.1720
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)