510(k) Report

Devices descending from K990214

450 later devices reach Fluoronav Module for the Stealthstation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K252847NextAR Hip PlatformMedacta International S.A.20260—
+11K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+11K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+11K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+11K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+11K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+11K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+11K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+11K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+11K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+11K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+11K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+11K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+11K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+11K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+11K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+12K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+12K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+12K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+12K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+12K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+12K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+12K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+12K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+12K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+12K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+12K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+13K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+13K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+13K243285TMINI Miniature Robotic SystemTHINK Surgical, Inc.20246—
+13K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+14K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.20255—
+14K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+14K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+15K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.20254—
+15K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+15K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+15K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+16K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+16K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+16K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+17K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+17K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+17K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+17K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+18K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+19K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601