510(k) Report

Devices descending from K110020

13 later devices reach Terason T3200 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+1K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+1K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+1K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+2K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+2K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+5K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+6K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+7K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—