# K913929: DFC-1024 & DFC-512 Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Imaging Systems
- Decided: Nov 27, 1991 after 85 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
53 later devices descend from it; 4 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971685: Imagescape Digital Retinal Image System (1997), 25 descendants of its own
- K980295: Ophthavision Imaging System (1998), 23 descendants of its own
- K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan (2009), 22 descendants of its own
- K101935: Centervue Digital Retinography System (2010), 21 descendants of its own
- K101861: Truevision 3D Visualization and Guidance System (2010), 13 descendants of its own

## Recalls of this device
- Dec 9, 2016 · Class II · Z-1017-2017: This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
- Dec 9, 2016 · Class II · Z-1142-2017: Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to p
- Apr 4, 2016 · Class II · Z-1681-2017: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
- Apr 4, 2016 · Class II · Z-1828-2017: During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
- Mar 28, 2016 · Class II · Z-1246-2017: Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Source page: https://510kreport.com/device/K913929
Methodology: https://510kreport.com/methodology