# K011418: Ultraguide MR-Guide 3000

- Pathway: 510(k) (Traditional)
- Applicant: Ultraguide, Ltd.
- Decided: May 24, 2001 after 15 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
No predicates in its family tree.
283 later devices descend from it; 3 cite it directly.
2 of 284 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
- K013150: MR-Guide 2000 (2001), 279 descendants of its own
- K053610: Abaris (2006), 278 descendants of its own
- K121498: Percunav (2012), 222 descendants of its own
- K132304: Epiq Diagnostic Ultrasound System (2013), 211 descendants of its own
- K160807: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (2016), 100 descendants of its own

Source page: https://510kreport.com/device/K011418
Methodology: https://510kreport.com/methodology