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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K254013
Device Name SubtleHD-PET (1.x)
Applicant
Subtle Medical, Inc.
883 Santa Cruz Ave.
Suite 205
Menlo Park,  CA  94025
Applicant Contact Alese Devin
Correspondent
Subtle Medical, Inc.
883 Santa Cruz Ave.
Suite 205
Menlo Park,  CA  94025
Correspondent Contact Adam Heroux
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/15/2025
Decision Date 05/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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