510(k) Report

Devices descending from K052358

56 later devices reach Etiam Star Pacs Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131392Etiam Pacs ComponentsEtiam S.A.S.U.20130—
+1K062488IQ-System Pacs SystemImage Information Systems, Ltd.200655—
+2K181318Onis-PacsDigitalcore Co., Ltd.20181—
+2K173241Med-TabPlum Medical Solutions GmbH20180—
+2K100837Pacentric Connect, Traveler and WebFimreite Software AS20100—
+2K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH200749—
+3K261874Syneris PACS v.1.0.1.0Syneris20260—
+3K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH20110—
+3K101342Osirix MDPixmeo Sarl201044—
+3K082041Fiatlux VisualizeFiatlux Imaging, Inc.20081—
+3K073176Kanteron Dicom Station (KDS), Model 3.0Monica Veytia20080—
+4K251030Sirona Advanced Imaging SuiteSirona Medical20250—
+4K232589Horos MD™Icat Solutions, Ltd.20241—
+4K212565CoverScan v1Perspectum, Ltd.20221—
+4K201092LSNImaging Biometrics, LLC20200—
+4K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+4K181460OnePacs SystemOnepacs, LLC20180—
+4K181962CubeVueCurvebeam, LLC20180—
+4K150976CollageAnatomage, Inc.20150—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+5K242552Horos MobileIcat Solutions, Ltd.20250—
+5K240839OpenRad CloudOpenrad Services Uk, Ltd.20240—
+5K231360Ambra PACSDicom Grid Dba Ambra Health202301
+5K230294CoverScan (CoverScan v1.1)Perspectum20230—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+6K243509Archer PSI System3D-Side20250—
+6K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+6K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+7K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+7K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+7K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+8K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+8K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+8K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+8K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+8K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+8K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+8K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+8K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+9K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+9K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+9K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+9K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+9K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+9K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+10K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+10K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+10K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+10K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+11K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—