510(k) Report

Devices descending from K040376

439 later devices reach Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+8K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+8K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+8K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+8K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+8K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+8K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+9K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+9K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+9K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+9K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+9K233457RUSHutom, Inc.20240—
+9K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+9K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+9K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+9K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+9K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+9K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+9K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+9K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+9K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+9K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+9K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+9K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+9K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+9K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+9K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+9K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+10K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+10K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+10K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+10K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+10K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+10K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+10K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+10K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+10K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+10K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+10K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+10K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+10K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+10K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+10K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+10K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+10K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+11K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+11K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+11K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+11K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+11K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+11K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+11K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+11K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+11K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+11K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+11K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+11K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+11K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+11K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+11K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+11K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—