510(k) Report

Devices descending from K200138

2 later devices reach Versana Premier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+2K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402