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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 K240290
Device Name AiMIFY (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.
Suite 120
South San Francisco,  CA  94080
Correspondent Contact Jared Seehafer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/01/2024
Decision Date 08/21/2024
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		 Yes
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