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FDA 510(k)

VARIAN HIGH ENERGY LINEAR ACCELERATOR

K-Number: K112839 · 2011-11-14

ApplicantVarian Medical Systems
Decision Date2011-11-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VARIAN HIGH ENERGY LINEAR ACCELERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2011-11-14 under 510(k) number K112839. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIAN HIGH ENERGY LINEAR ACCELERATOR?

VARIAN HIGH ENERGY LINEAR ACCELERATOR is a medical device that received FDA 510(k) clearance on 2011-11-14. The listed applicant is Varian Medical Systems. The 510(k) number is K112839.

When did VARIAN HIGH ENERGY LINEAR ACCELERATOR receive FDA 510(k) clearance?

VARIAN HIGH ENERGY LINEAR ACCELERATOR received FDA 510(k) clearance on 2011-11-14, under 510(k) number K112839.

Who is the listed applicant for VARIAN HIGH ENERGY LINEAR ACCELERATOR?

The FDA 510(k) record lists Varian Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIAN HIGH ENERGY LINEAR ACCELERATOR?

The FDA product code for VARIAN HIGH ENERGY LINEAR ACCELERATOR is IYE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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