510(k) Report

Devices descending from K191556

6 later devices reach Red Dot through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221552EFAI ChestSuite XR Pneumothorax Assessment SystemEver Fortune.Ai, Co., Ltd.20220—
+1K214043BriefCaseAidoc Medical, Ltd.20220—
+1K213941Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai20223—
+2K222179Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd.20231—
+2K222268Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd.20230—
+3K250831Annalise EnterpriseAnnalise-Ai20250—