FDA 510(k) Application Details - K232552

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K232552
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Tuxedo Imaging LLC 313 S. High St Akron, OH 44308 US Other 510(k) Applications for this Company
Contact	Patrick Williams Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2023
Decision Date	10/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review