SIGNA Creator, SIGNA Explorer— 510(k) K143251
Substantially EquivalentGe Healthcare (Ge Medical Systems, LLC)
FDA 510(k) clearance K143251 for SIGNA Creator, SIGNA Explorer, Substantially Equivalent on 2015-02-04. 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 K143251
K-number listed on FDA's recall record- Z-1239-2025 — SIGNA Creator, SIGNA Explorer, NMRI systems
- Z-1242-2025 — SIGNA MR355, SIGNA MR360, NMRI system
- Z-2470-2024 — SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Z-2472-2024 — SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Z-2473-2024 — SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Z-2475-2024 — SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
- Z-2476-2024 — SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
- Z-0596-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
- Z-0597-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
- Z-0137-2022 — SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
- Z-2058-2021 — SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
- Z-2059-2021 — SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
- Z-3026-2017 — SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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 1.5T SIGNA Creator and 1.5T SIGNA Explorer reflects 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-2731-2016 — GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143251.
Data sourced from openFDA. This site is unofficial and independent of the FDA.