FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: HI-ART SYSTEM
K Number: K033347
·
Decision Nov 12, 2003
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
23
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Basic Information
- Device Name
- MODIFICATION TO: HI-ART SYSTEM
- K Number
- K033347
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tomotherapy Incorporated
- Date Received
- October 20, 2003
- Decision Date
- November 12, 2003
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Tomotherapy Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | Dec 22, 2011 | Substantially Equivalent |
| K112446 | TOMOTHERAPY TREATMENT SYSTEM | Oct 7, 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 |