Helax-Tms V 5.1 Radiation Therapy Treatment Planning System
FDA 510(k) K010682 · Mds Nordion
510(k) numberK010682
Submission
- Device name
- Helax-Tms V 5.1 Radiation Therapy Treatment Planning System
- Applicant
- Mds Nordion
Ottawa, CA - Received
- March 7, 2001
- Decision date
- June 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Helax-Tms V 5.1 Radiation Therapy Treatment Planning System cleared by the FDA?
Helax-Tms V 5.1 Radiation Therapy Treatment Planning System (K010682) received a 510(k) decision of Substantially Equivalent on June 5, 2001, 90 days after the submission was received.
What is the product code of K010682?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.