FDA 510(k) Application Details - K232613

Device Classification Name	More FDA Info for this Device
510(K) Number	K232613
Device Name	CT Cardiomegaly
Applicant	Innolitics, LLC 1101 West 34th St Austin, TX 78705 US Other 510(k) Applications for this Company
Contact	Yujan Shrestha Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2023
Decision Date	02/28/2024
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