FDA 510(k) Application Details - K211715

Device Classification Name	System, Image Management, Ophthalmic   More FDA Info for this Device
510(K) Number	K211715
Device Name	System, Image Management, Ophthalmic
Applicant	RetinAI Medical AG Freiburgstrasse, 3 Bern 3010 CH Other 510(k) Applications for this Company
Contact	Enisa Dresevic 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	06/03/2021
Decision Date	04/28/2022
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