FDA 510(k) Application Details - K250684

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K250684
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	Terumo Cardiovascular Systems THI Plant 6190 Jackson Rd Ann Arbor, MI 48103 US Other 510(k) Applications for this Company
Contact	Rahul Reddy Chinkeri 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	03/06/2025
Decision Date	07/02/2025
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