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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Parathyroid Autofluorescence Imaging Device
510(k) Number K253303
Device Name Dendrite Imaging System
Applicant
Dendrite Imaging, Inc.
2198 6th St.
Berkeley,  CA  94710
Applicant Contact Ali Amiri
Correspondent
Decus Biomedical, Inc.
2342 Shattuck Ave.
Suite #333
Berkeley,  CA  94704
Correspondent Contact Terese Bogucki
Regulation Number878.4550
Classification Product Code
QDG  
Date Received09/29/2025
Decision Date 11/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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