BoneMRI v1.6— 510(k) K230197

Substantially Equivalent

Mriguidance B.V.

FDA 510(k) clearance K230197 for BoneMRI v1.6, Substantially Equivalent on 2023-02-22. 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: 2023-01-25
Decision date: 2023-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Utrecht, NL

Download summary PDF View on FDA.gov ↗

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