VECTRA MAGNETIC RESONANCE SYSTEM— 510(k) K913673

Clearance details

Applicant

General Electric Co.

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

1991-08-19

Decision date

1992-01-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Milwaukee, WI, US

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Death

11

Injury

670

Malfunction

1,460

Other

2

Total

2,143

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-0618-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.Class II·Ongoing·GE Healthcare, LLC·20211223

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K913673.