# K092837: Oti-Scan 3000

- Pathway: 510(k) (Special)
- Applicant: Opko Instrumentation, Inc.
- Decided: Dec 23, 2009 after 99 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: 3 generations back to K960622 (1996). 3 ancestors in all.
1 later device descends 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)
- K960622: I-SCAN, Ophthalmic Technologies, Inc. (1996) Summary page 1.
- K030770: Oti Scan with Transducers, Ophthalmic Technologies, Inc. (2003) Summary page 1.
- K031391: HF Module with Transducers, Ophthalmic Technologies, Inc. (2003) Summary page 1.

## Most influential descendants
- K103471: Ubm Plus (2011), 0 descendants of its own

## Indications for use
The OTI-Scan 3000 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 measurement of the axial length for determination of IOL power. Transducer for B-Scans with the OTI-Scan 3000 Ultrasound Imaging System.

Source page: https://510kreport.com/device/K092837
Methodology: https://510kreport.com/methodology