EFAI RTSUITE CT HCAP-Segmentation System
K-Number: K231928 · 2023-09-25
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2023-09-25
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI RTSUITE CT HCAP-Segmentation System is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2023-09-25 under approval 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. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K231928.
When was EFAI RTSUITE CT HCAP-Segmentation System approved by the FDA?
EFAI RTSUITE CT HCAP-Segmentation System received FDA 510(k) clearance on 2023-09-25, under approval number K231928.
What company makes EFAI RTSUITE CT HCAP-Segmentation System?
EFAI RTSUITE CT HCAP-Segmentation System is manufactured by Ever Fortune.Ai, Co., Ltd..
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.
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Related Devices (Code: QKB)
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.