FDA 510(k) Application Details - K243016

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K243016
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	SpectraWAVE, Inc. 12 Oak Park Dr. Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Ankit Shah 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	09/27/2024
Decision Date	03/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review