# K242198: ICS Dizcovery (1091)

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Denmark Aps
- Decided: Feb 14, 2025 after 203 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: 3 generations back to K991497 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151504: ICS Impulse, Gn Otometrics (2015) Summary page 6.

## Indications for use
ICS Dizcovery is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements. The 1091 ICS Dizcovery is used in the assessment of patients with complaints of a vestibular nature such as dizziness, disequilibrium, and vertigo. The ICS Dizcovery type 1091 does not treat or diagnose the patient; the diagnosis is determined by the credentialed physician. ICS Dizcovery system is intended to be used by qualified medical personnel. Typical device users are Neurologists, Ears, Nose, and Throat specialists (ENTs), Audiologists, Physical Therapists, and Technicians supervised by one of the four mentioned typical users. Professionals with knowledge of diagnosing balance disorders. Users are assumed to have prior knowledge of the medical and scientific facts underlying the procedures offered by the ICS Dizcovery system. The intended patient population are children in the age of 10 to 18 and adults in age range from 18 to 99 years with a complaint of dizziness, balance disorder, or vestibular disease.

Source page: https://510kreport.com/device/K242198
Methodology: https://510kreport.com/methodology