# K973950: Retinal Cube

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spectral Imaging, Ltd.
- Decided: Dec 12, 1997 after 57 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 K870039 (1987). 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)
- K870039: Imagenet Digital Ophthalmic Imaging System, Par Microsystems Corp. (1987) Summary page 1.

## Indications for use
An accessory to a fundus camera providing spectrally resolved images of the retina and optic disc and producing high contrast visualization of the blood vessels.

Source page: https://510kreport.com/device/K973950
Methodology: https://510kreport.com/methodology