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FDA 510(k)

SubtleHD-PET (1.x)

K-Number: K254013 · 2026-05-14

ApplicantSubtle Medical, Inc.
Decision Date2026-05-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SubtleHD-PET (1.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 2026-05-14 under 510(k) number K254013. 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 SubtleHD-PET (1.x)?

SubtleHD-PET (1.x) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Subtle Medical, Inc.. The 510(k) number is K254013.

When did SubtleHD-PET (1.x) receive FDA 510(k) clearance?

SubtleHD-PET (1.x) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K254013.

Who is the listed applicant for SubtleHD-PET (1.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 SubtleHD-PET (1.x)?

The FDA product code for SubtleHD-PET (1.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)K243250SubtleHD (1.x)K240290AiMIFY (1.x)K241329SubtleSYNTH (1.x)K233699SubtleREFORMAT (1.x)K223623SubtleMR (2.3.x)

View all 11 devices →

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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