# K964306: Magnetic Resonance Diagnostic Accessory

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Co.
- Decided: Jan 17, 1997 after 80 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 K942604 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942604: Signa Advantage SP Magnetic Resonance System, GE Medical Systems (1995) Summary page 1.

## Indications for use
The Signa SP Fiexible Colil family provides imaging capabiiity for the Signa SP MR System by facllitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.

Source page: https://510kreport.com/device/K964306
Methodology: https://510kreport.com/methodology