HI-ART SYSTEM— 510(k) K013673
Substantially EquivalentTomo Therapy, Inc.
FDA 510(k) clearance K013673 for HI-ART SYSTEM, Substantially Equivalent on 2002-01-28. Applicant: Tomo Therapy, Inc.. Device class: 2.
Clearance details
- Applicant
- Tomo Therapy, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middleton, WI, US
Recent devices under product code MUJ
view allData sourced from openFDA. This site is unofficial and independent of the FDA.