Mevatron 74X Medical Linear Accelerator

FDA 510(k) K791967 · Siemens Medical Laboratories, Inc.

Substantially Equivalent

510(k) numberK791967

Submission

Device name
Mevatron 74X Medical Linear Accelerator
Applicant
Siemens Medical Laboratories, Inc.
Walker, MI, US
Received
October 2, 1979
Decision date
November 16, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Mevatron 74X Medical Linear Accelerator cleared by the FDA?

Mevatron 74X Medical Linear Accelerator (K791967) received a 510(k) decision of Substantially Equivalent on November 16, 1979, 45 days after the submission was received.

What is the product code of K791967?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.