BoneMRI— 510(k) K260584

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.

Clearance details

Applicant
Mriguidance B.V.
Product code
Code QIH
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Utrecht, NL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.