BoneMRI— 510(k) K260584

Name: FDA 510(k) clearance K260584
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Substantially Equivalent

Mriguidance B.V.

FDA 510(k) clearance K260584 for BoneMRI, Substantially Equivalent on 2026-08-21. Applicant: Mriguidance B.V.. Device class: 2.

Summary

MRIguidance's BoneMRI is filed under product code QIH, automated radiological image processing software. The record has no description beyond the name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).

MRIguidance filed from Utrecht, Netherlands. FDA found it substantially equivalent 182 calendar days after receipt (February 20 to August 21, 2026).

Clearance details

Applicant: Mriguidance B.V.
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-02-20
Decision date: 2026-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utrecht, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

view all

K261733 — Ligence Heart2026-10-07
K262134 — NeuroDR2026-10-07
K260523 — QGuideCT (1.0)2026-10-05
K260055 — syngo.CT Brain Quantification2026-09-25
K262390 — BoneXpert2026-09-22

More clearances from Mriguidance B.V.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.