510(k) Report

Devices descending from K940172

119 later devices reach Cardiovascular Measurement System-CMS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+8K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+8K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+8K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+8K230803ADAS 3DAdas3D Medical S.L.20232—
+8K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+8K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+8K203744Arterys MICAArterys, Inc.20221—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K172574SyncVision SystemVolcano Corporation201701
+9K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+9K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+9K252539Tempus PixelArterys, Inc.20250—
+9K240791ADAS 3DAdas3D Medical S.L.20241—
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+10K253969ADAS 3DAdas3D Medical S.L.20260—
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+11K223233Monaco RTP SystemElekta Solutions AB20231—
+12K252002Monaco RTP System (6.3)Elekta Solutions AB20260—