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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Automated, Image Analysis, Operator Intervention
510(k) Number K260755
Device Name OptraSCAN System
Applicant
Optrascan, Inc.
2001 Gateway Pl.
Suite 150w
San Jose,  CA  95110
Applicant Contact Abhi Gholap
Correspondent
Addwin Consulting
Herndon,  VA  20171
Correspondent Contact Mona Advani
Regulation Number864.1860
Classification Product Code
NOT  
Date Received03/09/2026
Decision Date 07/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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