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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 K182336
Device Name SubtlePET
Applicant
Subtle Medical, Inc.
880 Santa Cruz Ave. Suite 200
Menlo Park,  CA  94025
Applicant Contact Enhao Gong
Correspondent
Decus Biomedical, Inc.
2342 Shattuck Ave., #333
Berkeley,  CA  94704
Correspondent Contact Terese Bogucki
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received08/28/2018
Decision Date 11/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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