510(k) Report

Devices descending from K212624

3 later devices reach EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232613CT CardiomegalyInnolitics, LLC20241—
+1K231149qXR-CTRQure.Ai Technologies20230—
+2K243859PRAEVAorta®2Nurea20250—