FDA 510(k) Application Details - K232555

Device Classification Name	System, Image Management, Ophthalmic   More FDA Info for this Device
510(K) Number	K232555
Device Name	System, Image Management, Ophthalmic
Applicant	Topcon Healthcare Solutions 111 Bauer Drive Oakland, NJ 07436 US Other 510(k) Applications for this Company
Contact	Tobias Schwarz 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	08/23/2023
Decision Date	11/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review