FDA 510(k) Application Details - K203578

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K203578
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	Perimeter Medical Imaging AI, Inc. 359 Eastern Avenue, Suite 110 Toronto M4M 1B7 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	12/07/2020
Decision Date	02/25/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review