510(k) Report

Devices descending from K162643

11 later devices reach MediGuide Technology System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201081AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V.20203—
+1K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+2K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+2K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+2K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+2K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+2K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V.20232—
+3K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+3K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+3K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20241—
+4K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V.20250—