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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K261305
Device Name MICSI-PET
Applicant
Microstructure Imaging, Inc.
370 Jay St.
Floor 7
Brooklyn,  NY  11201
Applicant Contact Gregory Lemberskiy
Correspondent
Highland Biomedical, Inc.
4190 Grove St.
Denver,  CO  80211
Correspondent Contact Adam Heroux
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received04/20/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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