FDA 510(k)

SubtleMR

K-Number: K191688 · 2019-09-16

Decision Date2019-09-16

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SubtleMR is the device name listed in this FDA 510(k) record. The listed applicant is Subtle Medical, Inc.. It received FDA 510(k) clearance on 2019-09-16 under 510(k) 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. The listed applicant is Subtle Medical, Inc.. The 510(k) number is K191688.

When did SubtleMR receive FDA 510(k) clearance?

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

Who is the listed applicant for SubtleMR?

The FDA 510(k) record lists Subtle Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SubtleMR?

The FDA product code for SubtleMR is LLZ.

Other records listing Subtle Medical, Inc. 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.

K254120SubtleHD-CT (1.x)K254013SubtleHD-PET (1.x)K243250SubtleHD (1.x)K240290AiMIFY (1.x)K241329SubtleSYNTH (1.x)K233699SubtleREFORMAT (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.