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FDA 510(k)

Varian High Energy Linear Accelerator

K-Number: K162476 · 2016-12-12

ApplicantVarian Medical Systems, Inc.
Decision Date2016-12-12
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, Inc.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162476. 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 2016-12-12. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K162476.

When did Varian High Energy Linear Accelerator receive FDA 510(k) clearance?

Varian High Energy Linear Accelerator received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162476.

Who is the listed applicant for Varian 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 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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