FDA 510(k) Application Details - K242778

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K242778
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Qpix Solutions Inc 1001 Aviation Parkway, Ste 200 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Seungman Yun 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	09/13/2024
Decision Date	10/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review