# K971685: Imagescape Digital Retinal Image System

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corporation USA
- Decided: Jun 24, 1997 after 48 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 K913929 (1991). 2 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913929: DFC-1024 & DFC-512 Digital Imaging System, Ophthalmic Imaging Systems (1991) Summary page 1.
- K952480: Orims Digital Angiography System, Midwest Ophthalmic Instruments, Inc. (1995) Summary page 1.
- (no number) Imagenet Digital Imaging System: named in the summary without a submission number

## Most influential descendants
- K980295: Ophthavision Imaging System (1998), 23 descendants of its own
- K101861: Truevision 3D Visualization and Guidance System (2010), 13 descendants of its own
- K141068: Zeiss Cataract Suite Markerless (2014), 8 descendants of its own
- K123464: Callisto Eye (2013), 6 descendants of its own
- K091935: Lipiview Ocular Surface Interferometer (2009), 6 descendants of its own

## Indications for use
The ImageScape is intended to capture, store, and manipulate digital images of the retina taken by a fundus camera.

Source page: https://510kreport.com/device/K971685
Methodology: https://510kreport.com/methodology