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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241329
Device Name SubtleSYNTH (1.x)
Applicant
Subtle Medical, Inc.
883 Santa Cruz Ave. Suite 205
Menlo Park,  CA  94025
Applicant Contact Ronny Elor
Correspondent
Enzyme Corporation
611 Gateway Blvd. #120
South San Francisco,  CA  94080
Correspondent Contact Jared Seehafer
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LNH  
Date Received05/10/2024
Decision Date 07/11/2024
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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