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FDA 510(k)

CorInsights MRI

K-Number: K193287 · 2020-11-20

ApplicantAdm Diagnostics, Inc.
Decision Date2020-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CorInsights MRI is a medical device manufactured by Adm Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-11-20 under approval number K193287. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorInsights MRI?

CorInsights MRI is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Adm Diagnostics, Inc.. The 510(k) number is K193287.

When was CorInsights MRI approved by the FDA?

CorInsights MRI received FDA 510(k) clearance on 2020-11-20, under approval number K193287.

What company makes CorInsights MRI?

CorInsights MRI is manufactured by Adm Diagnostics, Inc..

What is the FDA product code for CorInsights MRI?

The FDA product code for CorInsights MRI is LLZ.

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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.

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