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FDA 510(k)

SubtleMR

K-Number: K191688 · 2019-09-16

ApplicantSubtle Medical, Inc.
Decision Date2019-09-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SubtleMR is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2019-09-16 under approval number K191688. 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 SubtleMR?

SubtleMR is a medical device that received FDA 510(k) clearance on 2019-09-16. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K191688.

When was SubtleMR approved by the FDA?

SubtleMR received FDA 510(k) clearance on 2019-09-16, under approval number K191688.

What company makes SubtleMR?

SubtleMR is manufactured by Subtle Medical, Inc..

What is the FDA product code for SubtleMR?

The FDA product code for SubtleMR is LLZ.

Other Devices by Subtle Medical, Inc.

K182336SubtlePET K211964SubtlePET K203182SubtleMR K223623SubtleMR (2.3.x) K240290AiMIFY (1.x) K241329SubtleSYNTH (1.x)

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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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