# K974522: 3D I-Scan

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Technologies, Inc.
- Decided: Feb 25, 1998 after 85 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 K961403 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961403: Life Imaging Systems Lis 6000 a, Life Imaging Systems, Inc. (1996) Summary page 1.

## Indications for use
The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic B-scan Ultrasound system (K960622) to provide a three-dimensional visualization of the interior of the eye. The device is indicated when it is desirable to have a three-dimensional depiction (perspective rendering) of the interior of the globe for diagnostic purposes.

Source page: https://510kreport.com/device/K974522
Methodology: https://510kreport.com/methodology