Plato-Srs(Stereo Radiosurgery Treatment Planning Sys)
FDA 510(k) K940001 · Nucletron Corp.
510(k) numberK940001
Submission
- Device name
- Plato-Srs(Stereo Radiosurgery Treatment Planning Sys)
- Applicant
- Nucletron Corp.
Columbia, MD, US - Received
- January 3, 1994
- Decision date
- November 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Plato-Srs(Stereo Radiosurgery Treatment Planning Sys) cleared by the FDA?
Plato-Srs(Stereo Radiosurgery Treatment Planning Sys) (K940001) received a 510(k) decision of Substantially Equivalent on November 14, 1995, 680 days after the submission was received.
What is the product code of K940001?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.