Ctport CT Simulation System for Radiotherapy
FDA 510(k) K945838 · Toshiba America Medical Systems, In.C
510(k) numberK945838
Submission
- Device name
- Ctport CT Simulation System for Radiotherapy
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- November 29, 1994
- Decision date
- October 25, 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 Ctport CT Simulation System for Radiotherapy cleared by the FDA?
Ctport CT Simulation System for Radiotherapy (K945838) received a 510(k) decision of Substantially Equivalent on October 25, 1995, 330 days after the submission was received.
What is the product code of K945838?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.