510(k) Report

Devices descending from K201042

2 later devices reach Probeat-CR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260174Probeat-CRHitachi High-Tech Corp.20260—
+1K232032Probeat-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha202404