# K200529: Orion

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Aug 12, 2020 after 163 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 4.

## Indications for use
The Orion rotary chair is an optional accessory for VisualEyes 525/ VisualEyes 515 eye movement recording systems. The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.

Source page: https://510kreport.com/device/K200529
Methodology: https://510kreport.com/methodology