FDA 510(k) Application Details - K242239

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K242239
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	Gentuity, LLC 142 North Road, Suite G Sudbury, MA 01776 US Other 510(k) Applications for this Company
Contact	Edwin Rule 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	07/30/2024
Decision Date	08/16/2024
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