FDA 510(k) Application Details - K100625

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K100625
Device Name	Accelerator, Linear, Medical
Applicant	NAVOTEK MEDICAL LTD 1835 MARKET ST. 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	STEVEN B DATLOF, M.D., J.D. 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	03/04/2010
Decision Date	01/21/2011
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