FDA 510(k)

EFAI RTSUITE CT HCAP-Segmentation System

K-Number: K231928 · 2023-09-25

Decision Date2023-09-25

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EFAI RTSUITE CT HCAP-Segmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K231928. 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 HCAP-Segmentation System?

EFAI RTSUITE CT HCAP-Segmentation System is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K231928.

When did EFAI RTSUITE CT HCAP-Segmentation System receive FDA 510(k) clearance?

EFAI RTSUITE CT HCAP-Segmentation System received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231928.

Who is the listed applicant for EFAI RTSUITE CT HCAP-Segmentation System?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI RTSUITE CT HCAP-Segmentation System?

The FDA product code for EFAI RTSUITE CT HCAP-Segmentation System is QKB.

Other records listing Ever Fortune.Ai, Co., Ltd. as applicant

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.

K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)K251306Seg Pro V3 (RT-300)K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)K240291EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

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Related Devices (Code: QKB)

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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.