FDA.reportPublic FDA data

510(k) K261412

Device
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;
Applicant
Samsung Medison Co., Ltd.
510(k) number
K261412
Product code
IYN
Decision
Substantially Equivalent (SESE)
Decision date
2026-07-28
Date received
2026-04-30
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
Dayoung Choi
Address
3366, Hanseo-Ro, Nam-Myeon Hongcheon-Gun KR 25108 25108

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
K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC2026-08-07
K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-08-04
K261288Handheld Ultrasound ScannerIMGFAX CO., LTD.2026-07-30
K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics2026-07-30
K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2026-07-27
K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd2026-07-23
K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound systemEsonic Technology (Wuhan) Co., Ltd.2026-07-23
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