FDA 510(k) Application Details - K232828

Device Classification Name	System, Image Management, Ophthalmic   More FDA Info for this Device
510(K) Number	K232828
Device Name	System, Image Management, Ophthalmic
Applicant	Topcon Corporation 75-1 Hasunuma-Cho Itabashi-ku 174-8580 JP Other 510(k) Applications for this Company
Contact	Ryota Kitawaki Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	NFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2023
Decision Date	03/01/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review