Tomotherapy Incorporated - FDA 510(k) Cleared Devices
Recent clearances: TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER, TOMOTHERAPY TREATMENT SYSTEM, MODIFICATION TO HI-ART TREATMENT SYSTEM
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tomotherapy Incorporated Radiology ✕
6 devices
Cleared
Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
Radiology
87d
Cleared
Oct 07, 2011
TOMOTHERAPY TREATMENT SYSTEM
Radiology
44d
Cleared
Aug 25, 2008
MODIFICATION TO HI-ART TREATMENT SYSTEM
Radiology
42d
Cleared
Apr 19, 2006
MODIFICATION TO: HI-ART SYSTEM
Radiology
16d
Cleared
Nov 03, 2004
HI-ART SYSTEM
Radiology
30d
Cleared
Nov 12, 2003
MODIFICATION TO: HI-ART SYSTEM
Radiology
23d