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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 K213883
Device Name 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, PC
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact Jeffrey Gibbs
Regulation Number864.3700
Classification Product Code
PSY  
Date Received12/13/2021
Decision Date 09/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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