FDA 510(k)

BoneMRI v1.6

K-Number: K230197 · 2023-02-22

Decision Date2023-02-22

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BoneMRI v1.6 is the device name listed in this FDA 510(k) record. The listed applicant is Mriguidance B.V.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K230197. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BoneMRI v1.6?

BoneMRI v1.6 is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Mriguidance B.V.. The 510(k) number is K230197.

When did BoneMRI v1.6 receive FDA 510(k) clearance?

BoneMRI v1.6 received FDA 510(k) clearance on 2023-02-22, under 510(k) number K230197.

Who is the listed applicant for BoneMRI v1.6?

The FDA 510(k) record lists Mriguidance B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BoneMRI v1.6?

The FDA product code for BoneMRI v1.6 is QIH.

Other records listing Mriguidance B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233030BoneMRI K202404BoneMRI

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.