EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
FDA 510(k) K212624 · Ever Fortune.Ai, Co., Ltd.
510(k) numberK212624
Submission
- Device name
- EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
- Applicant
- Ever Fortune.Ai, Co., Ltd.
Taichung City, TW - Received
- August 18, 2021
- Decision date
- April 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
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Questions and answers
When was EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System cleared by the FDA?
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (K212624) received a 510(k) decision of Substantially Equivalent on April 4, 2022, 229 days after the submission was received.
What is the product code of K212624?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.