FDA 510(k) Application Details - K221106

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K221106
Device Name	System, Image Processing, Radiological
Applicant	Quantib BV Westblaak 106 Rotterdam 3012 KM NL Other 510(k) Applications for this Company
Contact	Arnault Massink 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	04/15/2022
Decision Date	05/13/2022
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