# K013150: MR-Guide 2000

- Pathway: 510(k) (Special)
- Applicant: Ultraguide, Ltd.
- Decided: Oct 18, 2001 after 28 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 K002258 (2000). 2 ancestors in all.
279 later devices descend from it; 1 cites it directly.
2 of 282 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011418: Ultraguide MR-Guide 3000, Ultraguide, Ltd. (2001) Summary page 1.
- K002258: Ultraguide CT-Guide 1010, Ultraguide, Ltd. (2000) Summary page 1.

## Most influential descendants
- 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
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own

## Indications for use
The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. It displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs. MR-Guide 2000 system also enables monitoring the respiratory phase of the patient. The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance imaging is currently used for visualizing such structures.

Source page: https://510kreport.com/device/K013150
Methodology: https://510kreport.com/methodology