FDA 510(k) Application Details - K203428

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K203428
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	Ziehm Imaging GmbH Lina-Ammon-Strasse 10 Nuremberg 90471 DE Other 510(k) Applications for this Company
Contact	Stefan Fiedler 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	11/20/2020
Decision Date	03/17/2021
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