# K843696: Ophthalmic a-Scan a-2000  Sonome

- Pathway: 510(k) (Traditional)
- Applicant: Sonomed Technology, Inc.
- Decided: Feb 26, 1985 after 160 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.
78 later devices descend from it; 2 cite it directly.
1 of 79 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K040668: E-Z Scan AB5500+ (2004), 76 descendants of its own
- K042467: Lso Pet/CT Hirez 64 (2004), 67 descendants of its own
- K050509: Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I (2005), 66 descendants of its own
- K060060: Biograph 6 (2006), 65 descendants of its own
- K060631: Biograph 64 and Biograph 40 (2006), 64 descendants of its own

Source page: https://510kreport.com/device/K843696
Methodology: https://510kreport.com/methodology