FDA 510(k) Application Details - K221257

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K221257
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	SpectraWAVE Inc 12 Oak Park Drive Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Farzad Parsaie 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	05/02/2022
Decision Date	02/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review