# K191804: TOMi Scope

- Pathway: 510(k) (Traditional)
- Applicant: Photonicare, Inc.
- Decided: Dec 5, 2019 after 153 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
Longest line of descent: 3 generations back to K944523 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133209: Foresee (4C) Imaging System, Diagnostic Photonics, Inc. (2014) Summary page 4.

## Indications for use
The TOMi 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 TOMi Scope is used to visualize the fluid density. The TOMi 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/K191804
Methodology: https://510kreport.com/methodology