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FDA 510(k)

BoneMRI

K-Number: K233030 · 2024-03-01

ApplicantMriguidance B.V.
Decision Date2024-03-01
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BoneMRI is a medical device manufactured by Mriguidance B.V.. It received FDA 510(k) clearance on 2024-03-01 under approval number K233030. 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?

BoneMRI is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Mriguidance B.V.. The 510(k) number is K233030.

When was BoneMRI approved by the FDA?

BoneMRI received FDA 510(k) clearance on 2024-03-01, under approval number K233030.

What company makes BoneMRI?

BoneMRI is manufactured by Mriguidance B.V..

What is the FDA product code for BoneMRI?

The FDA product code for BoneMRI is QIH.

Other Devices by Mriguidance B.V.

K202404BoneMRI K230197BoneMRI v1.6

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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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