FDA 510(k) Application Details - K213883

Device Classification Name	More FDA Info for this Device
510(K) Number	K213883
Device Name	NanoZoomer S360MD Slide scanner system
Applicant	Hamamatsu Photonics K.K. 812, Joko-cho, Higashi-ku Hamamatsu City 431-3196 JP Other 510(k) Applications for this Company
Contact	Shinichi Fujisaka Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2021
Decision Date	09/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review