Simulix Evolution
FDA 510(k) K033470 · Nucletron Corporation
510(k) numberK033470
Submission
- Device name
- Simulix Evolution
- Applicant
- Nucletron Corporation
Columbia, MD, US - Received
- November 3, 2003
- Decision date
- February 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Simulix Evolution cleared by the FDA?
Simulix Evolution (K033470) received a 510(k) decision of Substantially Equivalent on February 4, 2004, 93 days after the submission was received.
What is the product code of K033470?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.