# K031391: HF Module with Transducers

- Pathway: 510(k) (Special)
- Applicant: Ophthalmic Technologies, Inc.
- Decided: Jun 20, 2003 after 49 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
Longest line of descent: 2 generations back to K960622 (1996). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030770: Oti Scan with Transducers, Ophthalmic Technologies, Inc. (2003) Summary page 2.

## Most influential descendants
- K092837: Oti-Scan 3000 (2009), 1 descendant of its own
- K103471: Ubm Plus (2011), 0 descendants of its own

## Indications for use
Transducer for B-scans with OTI-Scan HF Module Transducer for B-scans with OTI-Scan HF Module ophthalmic system

Source page: https://510kreport.com/device/K031391
Methodology: https://510kreport.com/methodology