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FDA 510(k)

EFAI RTSuite CT HN-Segmentation System

K-Number: K220264 · 2022-04-28

ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2022-04-28
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EFAI RTSuite CT HN-Segmentation System is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-04-28 under approval number K220264. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EFAI RTSuite CT HN-Segmentation System?

EFAI RTSuite CT HN-Segmentation System is a medical device that received FDA 510(k) clearance on 2022-04-28. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K220264.

When was EFAI RTSuite CT HN-Segmentation System approved by the FDA?

EFAI RTSuite CT HN-Segmentation System received FDA 510(k) clearance on 2022-04-28, under approval number K220264.

What company makes EFAI RTSuite CT HN-Segmentation System?

EFAI RTSuite CT HN-Segmentation System is manufactured by Ever Fortune.Ai, Co., Ltd..

What is the FDA product code for EFAI RTSuite CT HN-Segmentation System?

The FDA product code for EFAI RTSuite CT HN-Segmentation System is QKB.

Other Devices by Ever Fortune.Ai, Co., Ltd.

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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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