510(k) Report

Devices descending from K003589

882 later devices reach Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+11K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+12K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+12K252544TMINI Miniature Robotic SystemTHINK Surgical, Inc.20253—
+12K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+12K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+12K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+12K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+12K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+12K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+12K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+12K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+12K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+12K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+12K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+12K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+12K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+12K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+12K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+12K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+12K191223NAVIOBlue Belt Technologies, Inc.201915—
+12K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+12K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+13K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+13K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+13K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+13K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K253661TMINI Miniature Robotic SystemTHINK Surgical, Inc.20252—
+13K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+13K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+13K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+13K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+13K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+13K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+13K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+13K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+13K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+13K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+13K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+13K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+13K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+13K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+14K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+14K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+14K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+14K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+14K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.202611
+14K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+14K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+14K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+14K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+14K212537Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202112—
+14K202789Monaco Rtp SystemElekta Solutions AB20213—
+14K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+15K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+15K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.202601
+15K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+15K213787Monaco RTP SystemElekta Solutions AB20222—
+15K220255Real Intelligence CoriBlue Belt Technologies, Inc.202211—
+15K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+16K223233Monaco RTP SystemElekta Solutions AB20231—
+16K220958Real Intelligence CoriBlue Belt Technologies, Inc.20220—
+16K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+17K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+17K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+18K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+19K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+20K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—