# K211118: Signa 7.0T

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: May 13, 2021 after 28 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K971684 (1997). 36 ancestors in all.
No later device cites it as a predicate yet.
5 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201615: Signa 7.0T, Ge Medical Systems, LLC (2020) Summary page 4.

## Recalls of this device
- Jun 14, 2024 · Class II · Z-2483-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions

## Indications for use
The SIGNA 7.0T 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 head and extremities. The images produced by the SIGNA 7.0T system 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. The device is intended for patients > 20 kg / 44 lb.

Source page: https://510kreport.com/device/K211118
Methodology: https://510kreport.com/methodology