# K990205: Digiscope Ophthalmic Camera

- Pathway: 510(k) (Traditional)
- Applicant: Eye Tel Imaging, Inc.
- Decided: Mar 26, 1999 after 64 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- 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 K913929 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971685: Imagescape Digital Retinal Image System, Tomey Corporation USA (1997) Summary page 1.
- K870039: Imagenet Digital Ophthalmic Imaging System, Par Microsystems Corp. (1987) Summary page 1.

## Indications for use
The Digiscope is indicated for use as an ophthalmic camera for individuals where examination of the fundus for pathologies is requested.

Source page: https://510kreport.com/device/K990205
Methodology: https://510kreport.com/methodology