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 a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2026-05-14 under approval 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. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K254013.
When was SubtleHD-PET (1.x) approved by the FDA?
SubtleHD-PET (1.x) received FDA 510(k) clearance on 2026-05-14, under approval number K254013.
What company makes SubtleHD-PET (1.x)?
SubtleHD-PET (1.x) is manufactured by Subtle Medical, Inc..
What is the FDA product code for SubtleHD-PET (1.x)?
The FDA product code for SubtleHD-PET (1.x) is LLZ.
Other Devices by Subtle Medical, Inc.
Related Devices (Code: LLZ)
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.