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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 K223623
Device Name SubtleMR (2.3.x)
Applicant
Subtle Medical Inc.
883 Santa Cruz Ave Suite 205
Menlo Park,  CA  94025
Applicant Contact Ajit Shankaranarayanan
Correspondent
Enzyme Corporation
611 Gateway Blvd #120
South San Francisco,  CA  94080
Correspondent Contact Jared Seehafer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/05/2022
Decision Date 05/11/2023
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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