510(k) Report

Devices descending from K063470

49 later devices reach Aycan Workstation Osirix through their predicates, nearest generation first.

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