OPTIMA MR450W— 510(k) K123522

Clearance details

Applicant

Ge Healthcare (Ge Medical Systems, LLC)

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2012-11-15

Decision date

2013-03-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Waukesha, WI, US

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• K132376 — DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T2013-11-15

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-3024-2017 — Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w 1.5T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.Class II·Terminated·GE Medical Systems, LLC·20170511

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123522.