510(k) Report

Devices descending from K234042

2 later devices reach EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262390BoneXpertVisiana20260—
+1K250914MediAI-BACrescom Co., Ltd.20250—