iQMR 1.2

by Medic Vision Imaging Solutions

iQMR 1.2 is a Class II device made by Medic Vision Imaging Solutions, cleared under FDA 510(k) K173605 on 8 Mar 2018 and listed in FDA GUDID since 11 Aug 2019 (UDI-DI 07290016836400), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290016836400 UDI-DI	Date11 Aug 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK173605	Date8 Mar 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016836400
FDA 510(k) database 510(k) number K173605

Across registries

2 registries list this device

FDA 510(k) K173605 decided 8 Mar 2018 Active
FDA GUDID UDI-DI 07290016836400 listed 11 Aug 2019 Listed

Timeline

2 dated events

8 Mar 2018 Cleared FDA 510(k) K173605
11 Aug 2019 Listed FDA GUDID 07290016836400

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: iQMR
Generic name: MRI system application software
Model / reference: 1.2

Primary DI / UDI-DI: 07290016836400
510(k) Number: K173605
FDA product code: LLZ
GMDN term: MRI system application software

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

Similar devices in this category

Other devices filed under MRI system application software.

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SafeCT-29

Class II

Properties

Serial number
Manufacturing date

Other properties (13, all answered No)