FDA 510(k) Application Details - K212890

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K212890
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	Omega Medical Imaging, LLC 3400 St. Johns Parkway, Suite 1020 Sanford, FL 32771 US Other 510(k) Applications for this Company
Contact	John Newman Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2021
Decision Date	12/13/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review