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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 K241121
Device Name MICSI-RMT
Applicant
Microstructure Imaging, Inc.
370 Jay St., 7th Floor
Brooklyn,  NY  11201
Applicant Contact Gregory Lemberskiy
Correspondent
Enzyme Corporation
611 Gateway Blvd.
Suite 120
South San Francisco,  CA  94080
Correspondent Contact Michelle Rubin-Onur
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/23/2024
Decision Date 07/17/2024
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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