HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM— 510(k) K993766
Substantially EquivalentHelax AB
FDA 510(k) clearance K993766 for HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM, Substantially Equivalent on 1999-12-08. Applicant: Helax AB. Device class: 2.
Clearance details
- Applicant
- Helax AB
- 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
- Special
- Location
- Ottawa, CA
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