BoneMRI v1.4— 510(k) K221762

Substantially Equivalent

Mrlguidance B.V.

FDA 510(k) clearance K221762 for BoneMRI v1.4, Substantially Equivalent on 2022-11-16. Applicant: Mrlguidance B.V.. Device class: 2.

Clearance details

Applicant: Mrlguidance B.V.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-06-17
Decision date: 2022-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
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.