# K983983: Edi Veris System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Diagnostic Imaging, Inc.
- Decided: Feb 3, 1999 after 86 days
- Product code: HLX (Photostimulator, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1630
- 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 K760199 (1976). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760199: Electroretinograph, Lkc Technologies, Inc. (1976) Summary page 1.
- K932571: Tomey PE-400 Portable Erg & Vep with Optional PS-4, Tomey Corporation USA (1995) Summary page 1.
- K863956: Maculoscope (TM), Doran Instruments, Inc. (1986) Summary page 1.

## Most influential descendants
- K043491: Enfanttm (2005), 1 descendant of its own
- K101763: Diopsys Nova Vep Vision Testing System (2011), 0 descendants of its own
- K022304: Accumap Automatic Perimeter (2003), 0 descendants of its own

## Indications for use
The VERIS system is an electhiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG) and visual evoked potential (VEP) signals, power spectra, and topographic maps. These functions are controlled and interpreted by trained medical professionals. The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.

Source page: https://510kreport.com/device/K983983
Methodology: https://510kreport.com/methodology