FDA 510(k)

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

K-Number: K212624 · 2022-04-04

Decision Date2022-04-04

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment 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 2022-04-04 under 510(k) number K212624. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System?

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is a medical device that received FDA 510(k) clearance on 2022-04-04. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K212624.

When did EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System receive FDA 510(k) clearance?

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System received FDA 510(k) clearance on 2022-04-04, under 510(k) number K212624.

Who is the listed applicant for EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment 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 Intelligent Cardiothoracic Ratio (iCTR) Assessment System?

The FDA product code for EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is QIH.

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

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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.