510(k) Report

Devices descending from K012191

25 later devices reach Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+1K030191Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp.200324—
+2K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+2K061153Gynesonics EC6 TransducerGynesonics, Inc.20067—
+2K032333Cryocare CS Surgical SystemEndocare, Inc.200313—
+3K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+3K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+3K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+4K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+4K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+4K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+5K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+5K101333Cryocare CS Surgical SystemEndocare, Inc.201082
+6K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+6K141110Cryocare CS Surgical SystemHealthtronics20157—
+7K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+7K153489Cryocare CS Surgical SystemHealthtronics20165—
+7K151968Cryocare CS-3 Surgical System version 5Healthtronics20156—
+8K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+8K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+9K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+9K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+9K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+9K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+9K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—