FDA 510(k) Application Details - K213544

Device Classification Name	More FDA Info for this Device
510(K) Number	K213544
Device Name	TOMTEC-ARENA
Applicant	TOMTEC Imaging Systems GmbH Freisinger Strasse 9 Unterschleissheim 85716 DE Other 510(k) Applications for this Company
Contact	Marc Bergenthal Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2021
Decision Date	01/06/2022
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