FDA 510(k) Application Details - K232293

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K232293
Device Name	Accelerator, Linear, Medical
Applicant	Kallisio, Inc 2925 Richmond Ave., Suite 1200 Houston, TX 77098 US Other 510(k) Applications for this Company
Contact	Rajan Patel Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2023
Decision Date	12/22/2023
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