# K980295: Ophthavision Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Mrp Group, Inc.
- Decided: May 19, 1998 after 112 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). 3 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 27 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.
- K971685: Imagescape Digital Retinal Image System, Tomey Corporation USA (1997) Summary page 1.
- (no number) Imagenet Digital Imaging System: named in the summary without a submission number

## Most influential descendants
- 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
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own

## Indications for use
The OphthaVision Imaging System is intended to be used to capture, archive and manipulate digital images of the eye obtained through the use of an ophthalmic camera.

Source page: https://510kreport.com/device/K980295
Methodology: https://510kreport.com/methodology