# K003575: Modification to 3.0T Signa VH/I Magnetic Resonance System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 17, 2001 after 58 days
- Product code: LNI (System, Nuclear Magnetic Resonance Spectroscopic)
- 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.
103 later devices descend from it; 2 cite it directly.
2 of 104 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
- 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

Source page: https://510kreport.com/device/K003575
Methodology: https://510kreport.com/methodology