# K945957: Ausonics Opus 2 Realtime Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Kleinfeld, Kaplan and Becker
- Decided: Apr 15, 1996 after 496 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981424: Nomos Bat Ultrasound Localization and Positioning System (1998), 10 descendants of its own
- K032100: I-BEAM (2003), 4 descendants of its own
- K042110: Beamcath (2005), 3 descendants of its own
- K041937: Restitu (2004), 3 descendants of its own
- K111332: Clarity Obp System (2012), 2 descendants of its own

Source page: https://510kreport.com/device/K945957
Methodology: https://510kreport.com/methodology