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FDA 510(k)

SubtleMR (2.3.x)

K-Number: K223623 · 2023-05-11

ApplicantSubtle Medical, Inc.
Decision Date2023-05-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SubtleMR (2.3.x) 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 2023-05-11 under 510(k) number K223623. 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 (2.3.x)?

SubtleMR (2.3.x) is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Subtle Medical, Inc.. The 510(k) number is K223623.

When did SubtleMR (2.3.x) receive FDA 510(k) clearance?

SubtleMR (2.3.x) received FDA 510(k) clearance on 2023-05-11, under 510(k) number K223623.

Who is the listed applicant for SubtleMR (2.3.x)?

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 (2.3.x)?

The FDA product code for SubtleMR (2.3.x) 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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Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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