Medical Device Manufacturer · US , Madison , WI

Tomotherapy Incorporated - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2003
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tomotherapy Incorporated Radiology ✕
6 devices
1-6 of 6
Cleared Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
K112776 · MUJ
Radiology · 87d
Cleared Oct 07, 2011
TOMOTHERAPY TREATMENT SYSTEM
K112446 · MUJ
Radiology · 44d
Cleared Aug 25, 2008
MODIFICATION TO HI-ART TREATMENT SYSTEM
K082005 · MUJ
Radiology · 42d
Cleared Apr 19, 2006
MODIFICATION TO: HI-ART SYSTEM
K060912 · IYE
Radiology · 16d
Cleared Nov 03, 2004
HI-ART SYSTEM
K042739 · MUJ
Radiology · 30d
Cleared Nov 12, 2003
MODIFICATION TO: HI-ART SYSTEM
K033347 · IYE
Radiology · 23d
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