# K033168: GE 0.2T Signa Profile/I MR System

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Oct 10, 2003 after 10 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992135 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992135: Signa Profile/I Magnetic Resonance System, Ge Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K043112: GE 0.2T Signa Profile Excite MR System (2004), 0 descendants of its own

## Indications for use
The Signa Profile/i MR system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Profile/i with High Slew Rate Option MR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa Profile/i MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (Ti), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Due to the 'open' design of the system, the Profileh with High Slew Rate Option MR system may also be utilized for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

Source page: https://510kreport.com/device/K033168
Methodology: https://510kreport.com/methodology