FDA 510(k) Application Details - K171560

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K171560
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	Perimeter Medical Imaging, Inc. 47 Colborne Street Suite 202 Toronto M5E 1P8 CA Other 510(k) Applications for this Company
Contact	Elizabeth Munro Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	NQQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2017
Decision Date	08/25/2017
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review