# K943315: Ultrasound Scanner 2002

- Pathway: 510(k) (Traditional)
- Applicant: B&K Medical
- Decided: Feb 9, 1996 after 578 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K992152: General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity Transducer Standoff (1999), 1 descendant of its own
- K080119: Clearscan (2008), 0 descendants of its own
- K991937: Ultrasound Scanner, Model Type 2101 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K943315
Methodology: https://510kreport.com/methodology