FDA 510(k) Application Details - K234067

Device Classification Name	More FDA Info for this Device
510(K) Number	K234067
Device Name	ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
Applicant	medPhoton GmbH Karolingerstra▀e. 16 Salzburg 5020 AT Other 510(k) Applications for this Company
Contact	Thomas Fessmann Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2023
Decision Date	03/28/2025
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