Therac 25 Linear Accelerator
FDA 510(k) K837152 · Atomic Energy of Canada
510(k) numberK837152
Submission
- Device name
- Therac 25 Linear Accelerator
- Applicant
- Atomic Energy of Canada
Kanata, Ontario, Canada, CA - Received
- February 28, 1982
- Decision date
- March 22, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Medical Intelligence Medizintechnik GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K850543 | Theratron 780C a Radionuclide Radiation Therapy SyIWB · Traditional | 05/10/1985SE |
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| K837346 | Model Gammacell 1000MOT · Traditional | 06/24/1983SE |
| K771260 | Linear Accelerator G-2900IYE · Traditional | 08/03/1977SE |
| K771096 | Telhtherapy Simulator Aecl-Cp, G-3200JAA · Traditional | 07/01/1977SE |
Questions and answers
When was Therac 25 Linear Accelerator cleared by the FDA?
Therac 25 Linear Accelerator (K837152) received a 510(k) decision of Substantially Equivalent on March 22, 1983, 387 days after the submission was received.
What is the product code of K837152?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.