VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K121062

Clearance details

Applicant

Ge Medical System Israel , Ltd.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2012-04-06

Decision date

2012-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wauwatosa, WI, US

• K261170 — BA-004CC2026-08-12
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• K260161 — SmartGuide Disposable Guides and Grids2026-07-30
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24

• K121063 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM2012-08-21
• K102393 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM2010-11-05
• K102388 — VIVID I DIAGNOSTIC ULTRASOUND SYSTEM2010-11-04

Death

6

Injury

137

Malfunction

2,036

Total

2,179

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-0757-2023 — Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).Class II·Ongoing·GE Medical Systems, LLC·20221110

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121062.