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FDA 510(k)

Eclipse Treatment Planning System

K-Number: K170969 · 2017-07-05

ApplicantVarian Medical Systems, Inc.
Decision Date2017-07-05
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Eclipse Treatment Planning System 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 2017-07-05 under 510(k) number K170969. 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?

Eclipse Treatment Planning System is a medical device that received FDA 510(k) clearance on 2017-07-05. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K170969.

When did Eclipse Treatment Planning System receive FDA 510(k) clearance?

Eclipse Treatment Planning System received FDA 510(k) clearance on 2017-07-05, under 510(k) number K170969.

Who is the listed applicant for Eclipse Treatment Planning System?

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 Eclipse Treatment Planning System?

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

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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