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FDA 510(k)

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator

K-Number: K181404 · 2018-06-28

ApplicantVarian Medical Systems, Inc.
Decision Date2018-06-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-06-28 under approval number K181404. 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, UNIQUE, Varian Multileaf Collimator?

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K181404.

When was Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator approved by the FDA?

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator received FDA 510(k) clearance on 2018-06-28, under approval number K181404.

What company makes Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator?

Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator?

The FDA product code for Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator 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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