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 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 2022-06-15 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K221448.

When did ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) receive FDA 510(k) clearance?

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

Who is the listed applicant for ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)?

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 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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Related Devices (Code: 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.