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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 K260964
Device Name NanoZoomer S540MD Slide Scanner System
Applicant
Hamamatsu Photonics K.K.
812, Joko-Cho, Chuo-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 Received03/23/2026
Decision Date 07/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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