FDA.reportPublic FDA data

510(k) K254028

Device
Digital 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)
Applicant
Sonoscape Medical Corp.
510(k) number
K254028
Product code
IYN
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-15
Date received
2025-12-16
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
N

Applicant Contact#

Contact
Toki Wu
Address
Rm. 201 & 202, 12th Bldg, Shenzhen Software Park Phase Ii 1 Keji Middle 2nd Rd., Yuehai Subdistrict, Nanshan District Shenzhen CN 518057 518057

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
K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-06-29
K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2026-06-16
K260748ES-SeriesE-Scopics2026-06-09
K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-05-27
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
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
K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-05-05
K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation2026-05-05
K260589ES-SeriesE-Scopics2026-04-29
K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.2026-04-06