510(k) Report

Devices descending from K220919

2 later devices reach MULTIX Impact E through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+1K233532MULTIX Impact ESiemens Medical Solutions20230—