# K051304: Iscience Surgical Ophthalmic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Science Surgical Corporation
- Decided: Jun 3, 2005 after 15 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 K003890 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003141: Ubm Plus, Model P45, Paradigm Medical Industries, Inc. (2000) Summary page 1.
- K021333: Artemis, Ultralink, LLC (2002) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The OIS provides real-time, high-resolution images of the intraocular anatomy and is, therefore, useful in evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, and glaucoma. It can also be used during ophthalmic surgery to monitor the changes in anatomical structures such as the anterior angle, Schlemm's canal and related outflow structures of the eye, for glaucoma management. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K051304
Methodology: https://510kreport.com/methodology