510(k) Report

Devices descending from K926351

360 later devices reach Colormark (TM) Visualization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K260748ES-SeriesE-Scopics20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+11K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+11K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+11K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+11K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+11K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+11K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+11K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+11K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+11K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+11K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+11K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+11K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+11K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+11K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+11K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+12K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+12K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+12K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+12K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+12K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+12K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+12K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+12K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+12K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+12K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+12K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+12K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+12K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+12K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+13K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+13K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+13K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+13K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+13K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+13K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+13K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+13K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+13K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+14K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+14K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+14K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+15K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—