FDA 510(k) Application Details - K221949

Device Classification Name	System, X-Ray, Tomographic   More FDA Info for this Device
510(K) Number	K221949
Device Name	System, X-Ray, Tomographic
Applicant	Pausch Medical GmbH Graf-Zeppelin-Strabe 1 Erlangen D-91056 DE Other 510(k) Applications for this Company
Contact	Christian Stoian Other 510(k) Applications for this Contact
Regulation Number	892.1740   More FDA Info for this Regulation Number
Classification Product Code	IZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2022
Decision Date	01/26/2023
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