# K974432: Ultraguide 1000 - Pathway: 510(k) (Traditional) - Applicant: Ultraguide, Ltd. - Decided: Feb 9, 1998 after 77 days - Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic) - Device class: 2 - Regulation: 21 CFR 892.1560 - 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 K882383 (1988). 3 ancestors in all. 358 later devices descend from it; 6 cite it directly. 2 of 362 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K926351: Colormark (TM) Visualization System, Echocath, Inc. (1993) Summary page 1. - K935456: Regulus Measurement Unit, Compass Intl., Inc. (1995) Summary page 1. - K882383: Maggi Series Ultra. Needle, Biopsy/Catheter Guides, CIVCO Medical Instruments Co., Inc. (1988) Summary page 1. - (no number) EchoTip Needles: named in the summary without a submission number ## Most influential descendants - K023227: USG 2000SA (2002), 280 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 ## Indications for use The UltraGuide 1000 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 wused in