# K926251: B-Scan Opthalmic Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Biovision, Inc.
- Decided: Sep 14, 1993 after 274 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.
26 later devices descend from it; 2 cite it directly.
0 of 27 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
- K993357: Iolmaster (2000), 17 descendants of its own
- K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter (2003), 16 descendants of its own
- K082891: Lenstar, Model LS900 (2009), 14 descendants of its own
- K101182: Iolmaster 500 (2010), 10 descendants of its own
- K122418: Iolmaster 500 (2013), 9 descendants of its own

Source page: https://510kreport.com/device/K926251
Methodology: https://510kreport.com/methodology