FDA 510(k) Application Details - K212230

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K212230
Device Name	System, Image Processing, Radiological
Applicant	Spectrum Dynamics Medical Ltd 22 Bareket St North Industrial Park Caesarea 3079837 IL Other 510(k) Applications for this Company
Contact	Igor Naroditsky 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	07/16/2021
Decision Date	08/16/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review