# K003613: 3.0.T Signa VH/I (T/R) Body Imaging Coil

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Apr 3, 2001 after 132 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.
108 later devices descend from it; 3 cite it directly.
3 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022397: Signa 3.0T Magnetic Resonance System (2002), 104 descendants of its own
- 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

Source page: https://510kreport.com/device/K003613
Methodology: https://510kreport.com/methodology