# K022354: Ultraguide CTG 2000SA

- Pathway: 510(k) (Special)
- Applicant: Ultraguide, Ltd.
- Decided: Aug 13, 2002 after 25 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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). 1 ancestor in all.
354 later devices descend from it; 3 cite it directly.
7 of 356 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002258: Ultraguide CT-Guide 1010, Ultraguide, Ltd. (2000)

## 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 CTG 2000sa system is a stereotactic accessory for Computed Tomography (CT) systems. It displays the simulated image of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the CT image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient. The device is intended to be used in clinical applications and for anatomical structures where computed tomography is currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K022354
Methodology: https://510kreport.com/methodology