FDA 510(k) Application Details - K213263

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K213263
Device Name	System, Image Processing, Radiological
Applicant	Image Instruments GmbH Niederwaldstr. 3 09123 Chemnitz DE Other 510(k) Applications for this Company
Contact	Greg Holland Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2021
Decision Date	01/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review