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 a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2022-04-04 under approval 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. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K212624.

When was EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System approved by the FDA?

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

What company makes EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System?

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is manufactured by Ever Fortune.Ai, Co., Ltd..

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.

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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.