510(k) Report

Devices descending from K944201

216 later devices reach HI-Q Hand Instruments- Urology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+11K172574SyncVision SystemVolcano Corporation201701
+12K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+12K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+12K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+12K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+12K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+13K251827Azurion R3.1Philips Medical Systems B.V.20251—
+13K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+13K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+13K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+14K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+14K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+14K254186Azurion R3.1Philips Medical Systems B.V.20260—
+14K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+14K233532MULTIX Impact ESiemens Medical Solutions20230—