Clinac 20 (Optional 18 MV Version)
FDA 510(k) K781057 · Varian Assoc., Inc.
510(k) numberK781057
Submission
- Device name
- Clinac 20 (Optional 18 MV Version)
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- June 23, 1978
- Decision date
- July 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Clinac 20 (Optional 18 MV Version) cleared by the FDA?
Clinac 20 (Optional 18 MV Version) (K781057) received a 510(k) decision of Substantially Equivalent on July 17, 1978, 24 days after the submission was received.
What is the product code of K781057?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.