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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Slide Imaging System
510(k) Number K251952
Device Name Virasight
Applicant
Virasoft Corporation
104 W 49th St.
Suites 400 And 500
New York City,  NY  10018
Applicant Contact Ted Regan Baird
Correspondent
Virasoft Corporation
104 W 49th St.
Suites 400 And 500
New York City,  NY  10018
Correspondent Contact Ted Regan Baird
Regulation Number864.3700
Classification Product Code
PSY  
Date Received06/25/2025
Decision Date 07/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
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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