# K102364: Nydiag 200

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Dec 23, 2010 after 125 days
- Product code: LXV (Apparatus, Vestibular Analysis)
- Device class: U
- 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 K922037 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922037: System 2000, Rotational Vestibular Chair, Micromedical Technologies, Inc. (1992) Summary page 1.

## Indications for use
The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.

Source page: https://510kreport.com/device/K102364
Methodology: https://510kreport.com/methodology