510(k) Report

Devices descending from K060059

2 later devices reach Aloka SD-3500 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111227Aloka SSD-3500 Diagnostic Ultrasound SystemAloka Co., Ltd.20111—
+2K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601