FDA 510(k) Application Details - K213660

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K213660
Device Name	System, Image Processing, Radiological
Applicant	Imaging Wave, LLC 7023 Juno Street Forrest Hills, NY 11375 US Other 510(k) Applications for this Company
Contact	Edward Kantor Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2021
Decision Date	03/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review