# K022858: Supernova Diagnostic Ultrasound Scanning System

- Pathway: 510(k) (Traditional)
- Applicant: Novasonics, Inc.
- Decided: Sep 6, 2002 after 9 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K002003 (2000). 2 ancestors in all.
134 later devices descend from it; 2 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002003: Hdi 5000 Ultrasound System with Extended Field of View Imaging, Atl Ultrasound, Inc. (2000)
- K011188: GE Logiq 9, Model 2188900-X, GE Medical Systems (2001)

## Most influential descendants
- K082326: Zonare Ultra Ultrasound System (2008), 133 descendants of its own
- K101091: Z.One Ultra Ultrasound System (2010), 132 descendants of its own
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System (2012), 98 descendants of its own
- K123622: Acuson (2012), 96 descendants of its own
- K123001: Acuson X700 Diagnstic Ultrasound System (2012), 74 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative (abdominal, thoracic, and vascular); Intra-operative Neuro; Pediatric; Small Organ (Thyroid, Breast, Testes, etc.); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Trans-esoph. (non-cardiac); Cardiac Adult; Cardiac Pediatric; Trans-esoph (Cardiac), Peripheral Vessel.

Source page: https://510kreport.com/device/K022858
Methodology: https://510kreport.com/methodology