# K173605: iQMR

- Pathway: 510(k) (Traditional)
- Applicant: Medic Vision - Imaging Solutions, Ltd.
- Decided: Mar 8, 2018 after 107 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922470 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993802: Sharpview Image Enhancement System, Context Vision AB (2000) Summary page 4.

## Indications for use
The iQMR is intended for networking, communication, processing and enhancement of MRI images in DICOM format. The device processing is not effective for lesion, mass, or abnormalities of sizes less than 1.5mm. This device is indicated for use by qualified trained medical professionals.

Source page: https://510kreport.com/device/K173605
Methodology: https://510kreport.com/methodology