# K030770: Oti Scan with Transducers

- Pathway: 510(k) (Special)
- Applicant: Ophthalmic Technologies, Inc.
- Decided: Mar 27, 2003 after 16 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: 1 generation back to K960622 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K960622: I-SCAN, Ophthalmic Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K031391: HF Module with Transducers (2003), 2 descendants of its own
- K092837: Oti-Scan 3000 (2009), 1 descendant of its own
- K103471: Ubm Plus (2011), 0 descendants of its own

## Indications for use
The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power. Transducer for B-scans with OTI-Scan Ophthalmic system Biometric and diagnostic A-scans with OTI-scan ophthalmic system

Source page: https://510kreport.com/device/K030770
Methodology: https://510kreport.com/methodology