# K023525: Retiscan, Retiport

- Pathway: 510(k) (Abbreviated)
- Applicant: Roland Consult
- Decided: Mar 26, 2004 after 522 days
- Product code: GWE (Stimulator, Photic, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1890
- 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 K863956 (1986). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863956: Maculoscope (TM), Doran Instruments, Inc. (1986) Summary page 1.
- K003442: Modification to Edi Veris System, Electro-Diagnostic Imaging, Inc. (2001)

## Most influential descendants
- K211643: Vision Monitor - MonpackONE (2021), 1 descendant of its own
- K081591: Neucodia (2009), 1 descendant of its own
- K221471: E3 and Profile (2022), 0 descendants of its own
- K212936: Vision Monitor- MonCvONE (2022), 0 descendants of its own
- K120104: Visionsearch 1 (2012), 0 descendants of its own

## Indications for use
Electrophysiological Test Unit for quantifying the retinal response, measuring a parameter (VEP) related to retinal response

Source page: https://510kreport.com/device/K023525
Methodology: https://510kreport.com/methodology