# K070670: Eyetracker/Ideas

- Pathway: 510(k) (Traditional)
- Applicant: S.A. Instrumentation Difra
- Decided: Sep 18, 2007 after 190 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- 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 K964325 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991497: Ics Medical Chartr Eng/VNG Diagnostic System, Ics Medical Corp. (1999) Summary page 2.
- K010059: Engplus, Western Systems Research, Inc. (2001) Summary page 2.
- K964325: Visualeyes: Video Eye Monitor, Micromedical Technologies, Inc. (1997) Summary page 2.
- K982103: Ulmer (VNG) Video Nystagmograph, Synapsys, Inc. (1998) Summary page 2.

## Cited in the summary but kept off the family tree
- K781268: Chair, Vestibular, Rotary, Comput., Contraves (1978). Our OCR of the scanned summary read K781268, FDA’s number for Chair, Vestibular, Rotary, Comput. (Contraves). Its FDA name has none of the distinctive words the summary uses for the device it names, “I-PORTAL, also known as I-PORTAL VNG, part of the NEURO-OTOLOGIC…”. Kept off the family tree. Summary page 2.

## Indications for use
The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function. The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

Source page: https://510kreport.com/device/K070670
Methodology: https://510kreport.com/methodology