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510(k) K192226

Device
Lumify Diagnostic Ultrasound System
Applicant
Philips Healthcare
510(k) number
K192226
Product code
IYN  
Decision
Substantially Equivalent (SESE)
Decision date
2019-09-06
Date received
2019-08-16
Regulation
892.1550
Classification name
System, Imaging, Pulsed Doppler, Ultrasonic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Paul Elias
Address
22100 Bothell Everett Hwy. Bothell WA US 98021 98021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IYN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC2026-05-27
K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics2026-05-26
K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6CHISON Medical Technologies Co., Ltd.2026-05-22
K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteWuhan United Imaging Healthcare Co.,Ltd2026-05-21
K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)Sonoscape Medical Corp.2026-05-15
K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperWuhan United Imaging Healthcare Co.,Ltd2026-05-15
K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.2026-05-14
K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);DiagnosShenzhen Mindray Bio-Medical Electronics Co., Ltd.2026-05-11
K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation2026-05-05
K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-05-05
K260589ES-SeriesE-Scopics2026-04-29
K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.2026-04-06
K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.2026-04-02
K252148Butterfly Gestational Age ToolButterfly Network, Inc.2026-03-27
K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-03-27

Legacy Summary#

summary

FDA Review#

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