DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T— 510(k) K132376
Substantially EquivalentGe Healthcare (Ge Medical Systems, LLC)
FDA 510(k) clearance K132376 for DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T, Substantially Equivalent on 2013-11-15. Applicant: Ge Healthcare (Ge Medical Systems, LLC). Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code LNH
view allMore clearances from Ge Healthcare (Ge Medical Systems, LLC)
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K132376
K-number listed on FDA's recall record- Z-2302-2025 — GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
- Z-2468-2024 — Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Z-0593-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
- Z-0594-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
- Z-0601-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
- Z-0602-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
- Z-3022-2017 — Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners 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, 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 1 .5T Brivo MR355 and I .5T Optima MR360 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.
- Z-3023-2017 — Optima MR750 3.0T Product Usage: The Optima MR450 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 MR450 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.
- 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.
- Z-3025-2017 — Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem 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 Discovery MR750 3.0T 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.
- Z-1188-2017 — Discovery MR450 The systems are whole body magnetic resonance scanners 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.
- Z-2131-2016 — GE Healthcare, Discovery MR750w
- Z-0201-2019 — GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
- Z-0254-2016 — GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
- Z-0259-2016 — GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132376.
Data sourced from openFDA. This site is unofficial and independent of the FDA.