# K972296: Magnetic Resonance Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Sep 15, 1997 after 88 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Signa Profile System (software and electronics): named in the summary without a submission number
- (no number) Signa Profile Extremity Coil: named in the summary without a submission number

## Most influential descendants
- K041921: GE Signa Profile 6 Inch GP Coil (2004), 0 descendants of its own

## Indications for use
The Indications for Use for the Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the knee and surrounding structures. The 9 inch Coil is intended for imaging of the cervical spine, shoulder, knee and surrounding structures.

Source page: https://510kreport.com/device/K972296
Methodology: https://510kreport.com/methodology