FDA 510(k) Application Details - K171098

Device Classification Name	System, Image Management, Ophthalmic   More FDA Info for this Device
510(K) Number	K171098
Device Name	System, Image Management, Ophthalmic
Applicant	Sonomed, Inc. 1979 Marcus Ave, Suite C105 New Hyde Park, NY 11042 US Other 510(k) Applications for this Company
Contact	Mark Wallace 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	04/13/2017
Decision Date	05/02/2017
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	Y
Expedited Review