FDA.reportPublic FDA data

510(k) K231965

Device
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
510(k) number
K231965
Product code
IYN
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-30
Date received
2023-07-03
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
No

Applicant Contact#

Contact
Bryan Behn
Address
Llc 9900 Innovations Dr. Wauwatosa WI US 53226 53226

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
K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics2026-09-02
K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)Sonoscape Medical Corp.2026-08-24
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
K261412V8/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;Samsung Medison Co., Ltd.2026-07-28
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