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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 K253606
Device Name NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
Applicant
Hamamatsu Photonics K.K.
812, Joko-Cho, Higashi-Ku
Hamamatsu City,  JP 431-3196
Applicant Contact Shinichi Fujisaka
Correspondent
Hyman, Phelps & McNamara, P.C.
1101 K St. NW Suite 700
Washington,  DC  20005
Correspondent Contact Adrienne Lenz
Regulation Number864.3700
Classification Product Code
PSY  
Date Received11/18/2025
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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