FDA 510(k) Application Details - K241174

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K241174
Device Name	System, Therapeutic, X-Ray
Applicant	Carl Zeiss Meditec AG Rudolf-Eber-Strasse 11 Oberkochen 73447 DE Other 510(k) Applications for this Company
Contact	Anke Seitz Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2024
Decision Date	01/10/2025
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