Vivid E80, Vivid E90, Vivid E95— 510(k) K170823

Clearance details

Applicant

GE Medical Systems Ultrasound and Primary Care Diagnostics

Product code

Product code IYN

Device class

Class 2

Regulation

21 CFR 892.1550

Advisory panel

Radiology

Date received

2017-03-20

Decision date

2017-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wauwatosa, WI, US

• 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

• K261623 — EchoPAC Software Only / EchoPAC Plug-in (v211)2026-09-16
• K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus2026-09-02
• K261835 — LOGIQ Focus2026-07-30
• K260398 — LOGIQ e2026-05-26
• K260673 — LOGIQ Vita +9 more2026-03-24

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-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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170823.