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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, tomography, computed, emission
510(k) Number K211964
Device Name SubtlePET
Subtle Medical, Inc.
883 Santa Cruz Ave, Suite 205
Menlo Park,  CA  94025
Applicant Contact Ajit Shankaranarayanan
Enzyme Corporation
611 Gateway Blvd #120
South San Francisco,  CA  94080
Correspondent Contact Jared Seehafer
Regulation Number892.1200
Classification Product Code
Subsequent Product Code
Date Received06/24/2021
Decision Date 09/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No