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FDA 510(k)

BoneMRI v1.6

K-Number: K230197 · 2023-02-22

ApplicantMriguidance B.V.
Decision Date2023-02-22
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BoneMRI v1.6 is a medical device manufactured by Mriguidance B.V.. It received FDA 510(k) clearance on 2023-02-22 under approval 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. It is manufactured by Mriguidance B.V.. The 510(k) number is K230197.

When was BoneMRI v1.6 approved by the FDA?

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

What company makes BoneMRI v1.6?

BoneMRI v1.6 is manufactured by Mriguidance B.V..

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

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

Other Devices by Mriguidance B.V.

K202404BoneMRI K233030BoneMRI

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Official Source

View on FDA Database →

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

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