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..

Clearance details

Applicant: Mriguidance B.V.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2023-01-25
Decision date: 2023-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Utrecht, NL

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