# K000368: Eyecap Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Clement Clarke Intl., Ltd.
- Decided: May 4, 2000 after 90 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
No predicates in its family tree.
7 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110129: Righton Zoom Slit Lamp Microscope with Photo Option (2011), 5 descendants of its own
- K133476: Slit Lamps with SL Cam 5.0 Digital Imaging Solution (2014), 4 descendants of its own
- K162684: SL 220 (2017), 1 descendant of its own
- K253834: Visuref 600 (2026), 0 descendants of its own
- K163564: Slit Lamp SL-2000 (2017), 0 descendants of its own

## Indications for use
The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.

Source page: https://510kreport.com/device/K000368
Methodology: https://510kreport.com/methodology