510(k) Report

Devices descending from K162549

43 later devices reach Lumify Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+1K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+1K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+1K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+2K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+2K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+2K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+2K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+2K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+2K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+2K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+2K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+2K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+2K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+2K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+3K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+3K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+3K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+3K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+3K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+3K211527Exo IrisExo Imaging, Inc.20211—
+4K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+4K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+4K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+4K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+4K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+5K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+5K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+5K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+6K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+6K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+6K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+6K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+6K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+6K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+7K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+7K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+7K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+7K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+8K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+8K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+9K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—