Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System— 510(k) K150087

Clearance details

Applicant

Ge Vingmed Ultrasound AS

Product code

Product code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2015-01-15

Decision date

2015-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Horten, NO

• K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more2026-10-16
• K261617 — Diagnostic Ultrasound System (11+ models)2026-10-08
• K263150 — V10 Diagnostic Ultrasound System +10 more2026-10-08
• K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 222026-10-02
• K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System2026-09-25

• K150085 — GE EchoPAC2015-03-02
• K141093 — 6VT-D ULTRASOUND TRANSDUCER2014-05-15
• K131685 — GE ECHOPAC2013-09-24
• K131514 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM2013-07-12
• K123894 — GE ECHOPAC2013-01-29

Death

25

Injury

163

Malfunction

1,538

Other

4

Total

1,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2316-2024 — GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DAClass II·Ongoing·GE Vingmed Ultrasound As·20240502
• Z-2986-2018 — GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).Class II·Terminated·GE Medical Systems Ultrasound & Primary Care Diagnostics, LL·20180322
• Z-2987-2018 — GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).Class II·Terminated·GE Medical Systems Ultrasound & Primary Care Diagnostics, LL·20180322
• Z-2988-2018 — GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).Class II·Terminated·GE Medical Systems Ultrasound & Primary Care Diagnostics, LL·20180322
• Z-1779-2017 — Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.Class II·Terminated·GE Healthcare, LLC·20170310
• Z-1780-2017 — Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.Class II·Terminated·GE Healthcare, LLC·20170310

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150087.