FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOMOTHERAPY TREATMENT SYSTEM
K Number: K112446
·
Decision Oct 7, 2011
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
255
Applicant Total
6
Review Days
44
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TOMOTHERAPY TREATMENT SYSTEM
- K Number
- K112446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tomotherapy Incorporated
- Date Received
- August 24, 2011
- Decision Date
- October 7, 2011
- Product Code
- MUJ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUJ), ordered by most recent decision date.
RadOncAI
FDA 510(k)
FDA Class 2
·Radiology
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
FDA 510(k)
FDA Class 2
·Radiology
eXaSkin Plus
FDA 510(k)
FDA Class 2
·Radiology
ART.1-US
FDA 510(k)
FDA Class 2
·Radiology
syngo.via RT Image Suite VC10
FDA 510(k)
FDA Class 2
·Radiology
TrueFit Bolus
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Tomotherapy Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | Dec 22, 2011 | Substantially Equivalent |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | Aug 25, 2008 | Substantially Equivalent |
| K060912 | MODIFICATION TO: HI-ART SYSTEM | Apr 19, 2006 | Substantially Equivalent |
| K042739 | HI-ART SYSTEM | Nov 3, 2004 | Substantially Equivalent |
| K033347 | MODIFICATION TO: HI-ART SYSTEM | Nov 12, 2003 | Substantially Equivalent |