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FDA 510(k)

HIGH ENERGY LINEAR ACCELERATOR

K-Number: K131807 · 2013-10-11

ApplicantVarian Medical Systems, Inc.
Decision Date2013-10-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HIGH ENERGY LINEAR ACCELERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-10-11 under 510(k) number K131807. 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 HIGH ENERGY LINEAR ACCELERATOR?

HIGH ENERGY LINEAR ACCELERATOR is a medical device that received FDA 510(k) clearance on 2013-10-11. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K131807.

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

HIGH ENERGY LINEAR ACCELERATOR received FDA 510(k) clearance on 2013-10-11, under 510(k) number K131807.

Who is the listed applicant for HIGH ENERGY LINEAR ACCELERATOR?

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

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

The FDA product code for 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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