# K991497: Ics Medical Chartr Eng/VNG Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Ics Medical Corp.
- Decided: Jul 28, 1999 after 90 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
No predicates in its family tree.
10 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 2D VOG-VIDEO-OCULOGRAPHY device: named in the summary without a submission number
- (no number) Chartr® Eng System: named in the summary without a submission number

## Most influential descendants
- K061791: Focus VNG/Eng Type 1068 (2006), 4 descendants of its own
- K151504: ICS Impulse (2015), 3 descendants of its own
- K050098: Ddat Omt (2005), 1 descendant of its own
- K242198: ICS Dizcovery (1091) (2025), 0 descendants of its own
- K242726: Synapsys VHIT (2025), 0 descendants of its own

## Indications for use
This device is used to observe, record and measure eye movements in patients during testing of vestibular function.

Source page: https://510kreport.com/device/K991497
Methodology: https://510kreport.com/methodology