# K960622: I-SCAN

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Technologies, Inc.
- Decided: May 13, 1996 after 90 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sonomed Model A2500 ultrasound system: named in the summary without a submission number
- (no number) Biophysic Ophthascan B system: named in the summary without a submission number

## Most influential descendants
- K030770: Oti Scan with Transducers (2003), 3 descendants of its own
- 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
- K024114: A-SCAN 100 (2003), 0 descendants of its own

## Indications for use
The OTI 1i+tech “i-scan” ultrasound system is 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.

Source page: https://510kreport.com/device/K960622
Methodology: https://510kreport.com/methodology