# K222655: OtoSight Middle Ear Scope

- Pathway: 510(k) (Special)
- Applicant: Photonicare, Inc.
- Decided: Sep 26, 2022 after 24 days
- Product code: QJG (Device System, Imaging, Tympanic Membrane And Middle Ear)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.

Source page: https://510kreport.com/device/K222655
Methodology: https://510kreport.com/methodology