# K022397: Signa 3.0T Magnetic Resonance System

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Aug 22, 2002 after 30 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: 1 generation back to K990550 (1999). 2 ancestors in all.
104 later devices descend from it; 2 cite it directly.
3 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003613: 3.0.T Signa VH/I (T/R) Body Imaging Coil, GE Medical Systems (2001) Summary page 1.
- K990550: 3.0T Signa VH/I Magnetic Resonance System, Ge Medical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K030874: GE 3.0T Signa Infinity Twinspeed with Excite MR System (2003), 100 descendants of its own
- K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System (2004), 99 descendants of its own
- K052293: GE 1.5T and 3.0T Signa HDX MR System (2005), 90 descendants of its own
- K081028: Signa 3.0T MR750 System (2008), 70 descendants of its own
- K083147: Discovery MR450 (2008), 69 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0612-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

## Indications for use
The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomeflhorax and the extremities.

Source page: https://510kreport.com/device/K022397
Methodology: https://510kreport.com/methodology