# K974535: Discam Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Marcher Enterprises, Ltd.
- Decided: Aug 14, 1998 after 255 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: 1 generation back to K912891 (1991). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954780: Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C, Kowa Optimed, Inc. (1995) Summary page 1.
- K913929: DFC-1024 & DFC-512 Digital Imaging System, Ophthalmic Imaging Systems (1991) Summary page 1.
- K923742: Topographic Scanning System Topss, Carl Zeiss Meditec, Inc. (1993) Summary page 1.
- K912891: Heidelberg Retina Tomograph, Heidelberg Engineering (1991) Summary page 1.

## Most influential descendants
- K102412: Vista Digital Opthalmoscope (2011), 2 descendants of its own
- K121405: Panoptic (2012), 1 descendant of its own
- K223381: iExaminer System with Panoptic Plus (2023), 0 descendants of its own

## Indications for use
The Discam® Digital Imaging System is intended to be used to evaluate the Optic Disc, (Optic Nerve Head). It is used in the same fashion as a Fundus camera, except that it's field of view is narrower, in order to focus exclusively on the Optic Disc, (Optic Nerve Head). Evaluation of changes in the size and shape of the Optic Disc, (Optic Nerve Head), is useful in monitoring the progress of patients with Ocular Hypertension, and Glaucoma.

Source page: https://510kreport.com/device/K974535
Methodology: https://510kreport.com/methodology