FDA 510(k)

Eclipse Treatment Planning System v16.1

K-Number: K201607 · 2020-07-10

Decision Date2020-07-10

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Eclipse Treatment Planning System v16.1 is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-07-10 under approval number K201607. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse Treatment Planning System v16.1?

Eclipse Treatment Planning System v16.1 is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K201607.

When was Eclipse Treatment Planning System v16.1 approved by the FDA?

Eclipse Treatment Planning System v16.1 received FDA 510(k) clearance on 2020-07-10, under approval number K201607.

What company makes Eclipse Treatment Planning System v16.1?

Eclipse Treatment Planning System v16.1 is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Eclipse Treatment Planning System v16.1?

The FDA product code for Eclipse Treatment Planning System v16.1 is MUJ.

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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.