Saturne Multileaf Collimator
FDA 510(k) K970303 · General Electric Co.
510(k) numberK970303
Submission
- Device name
- Saturne Multileaf Collimator
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- January 27, 1997
- Decision date
- April 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Saturne Multileaf Collimator cleared by the FDA?
Saturne Multileaf Collimator (K970303) received a 510(k) decision of Substantially Equivalent on April 25, 1997, 88 days after the submission was received.
What is the product code of K970303?
The FDA product code is IXI – Block, Beam-Shaping, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5710.