GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2— 510(k) K082185

Clearance details

Applicant

Ge Medical Systems Ultrasound and Primary Care Dia

Product code

Code IYO

Device class

Class 2

Regulation

21 CFR 892.1560

Advisory panel

Radiology

Date received

2008-08-01

Decision date

2008-08-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Wauwatosa, WI, US

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Malfunction

3,339

Total

3,339

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-2983-2018 — GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and 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 K082185.