FDA 510(k) Application Details - K023519

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K023519
Device Name	Accelerator, Linear, Medical
Applicant	RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	KEVIN J O'CONNELL 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	10/21/2002
Decision Date	01/16/2003
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