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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 K191688
Device Name SubtleMR
Subtle Medical, Inc.
883 Santa Cruz Ave, Suite 205
Menlo Park,  CA  94025
Applicant Contact Ajit Shankaranarayanan
Enzyme Corporation
360 Langton St.
Ste. 100
San Francisco,  CA  94103
Correspondent Contact Jared Seehafer
Regulation Number892.2050
Classification Product Code
Date Received06/24/2019
Decision Date 09/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No