EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
510(k) K212624
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212624 | Date4 Apr 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is a medical imaging software designed to automatically evaluate the cardiothoracic ratio (CTR) from chest X-ray images. It measures the maximal transverse diameter of the heart and the maximal inner transverse diameter of the thoracic cavity, then calculates the CTR to assist in diagnostic assessments. This system falls under the category of radiologic software for image analysis and quantification. Its primary function is to provide objective, automated measurements to support clinical decision-making in cardiothoracic evaluations.
The iCTR Assessment System is intended for use in hospital and clinic settings by radiologists or trained personnel to analyze posterior-anterior (PA) chest X-ray images. It is supplied as a software solution, requiring integration with existing X-ray imaging systems to process and analyze images. The system is not described as single-use or reusable, as it operates as a digital tool with no physical consumables. No specific sterility, MRI safety, or size-related constraints are noted in the provided data. The device holds FDA 510(k) clearance under K212624, classified under product code QIH and reviewed by the Radiology Advisory Committee.
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Questions
AI-generated answers, 1 Oct 2026
What is the EFAI iCTR Assessment System used for?
The EFAI iCTR Assessment System is a medical imaging software designed to automatically evaluate the cardiothoracic ratio (CTR) from posterior-anterior (PA) chest X-ray images. It measures the heart’s maximal transverse diameter and the thoracic cavity’s inner diameter, then calculates the CTR to provide objective, automated measurements. This supports radiologists and trained personnel in clinical decision-making for cardiothoracic evaluations, reducing variability in manual assessments.
How is the EFAI iCTR Assessment System supplied and integrated?
The system is supplied as a software solution that requires integration with existing X-ray imaging systems. It is not a standalone physical device but operates as a digital tool that processes and analyzes PA chest X-ray images. Integration ensures compatibility with the hospital or clinic’s imaging infrastructure, enabling seamless analysis and reporting of CTR measurements.
Is the EFAI iCTR Assessment System single-use or reusable?
The EFAI iCTR Assessment System is neither single-use nor reusable in the traditional sense, as it functions as a digital software tool with no physical consumables. It is designed for repeated use within integrated imaging systems, provided the software remains updated and the underlying hardware (e.g., X-ray systems) meets compatibility requirements. No sterility or physical disposal considerations apply.
Does the EFAI iCTR Assessment System require any specific storage conditions?
As a software-based system, the EFAI iCTR Assessment System does not have physical storage requirements like temperature or humidity constraints. However, it must be installed on compliant hardware with sufficient processing power and storage capacity to run the software. Regular software updates and system maintenance are recommended to ensure optimal performance and compliance with regulatory standards.
What regulatory clearance does the EFAI iCTR Assessment System hold?
The EFAI iCTR Assessment System holds FDA 510(k) clearance under the reference number K212624. It was classified under product code QIH and reviewed by the Radiology Advisory Committee, with a decision of substantial equivalence (SESE). This clearance confirms its compliance with U.S. regulatory requirements for radiologic software used in image analysis and quantification.