# K023227: USG 2000SA

- Pathway: 510(k) (Special)
- Applicant: Ultraguide, Ltd.
- Decided: Oct 22, 2002 after 25 days
- Product code: HHJ (Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.2225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882383 (1988). 4 ancestors in all.
280 later devices descend from it; 2 cite it directly.
2 of 285 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974432: Ultraguide 1000, Ultraguide, Ltd. (1998) 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 UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K023227
Methodology: https://510kreport.com/methodology