FDA 510(k)

ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)

K-Number: K221448 · 2022-06-15

Decision Date2022-06-15

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-06-15 under approval number K221448. 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 ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)?

ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K221448.

When was ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) approved by the FDA?

ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) received FDA 510(k) clearance on 2022-06-15, under approval number K221448.

What company makes ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)?

ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)?

The FDA product code for ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) is IYE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.