# K152661: HICAT Air

- Pathway: 510(k) (Traditional)
- Applicant: Hicat GmbH
- Decided: Nov 16, 2015 after 60 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924630 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133320: Sicat Function, Sicat GmbH & Co. KG (2014) Summary page 4.

## Indications for use
HICAT Air is a software application for: • Aiding diagnosis in the ear-nose-throat region • Aiding treatment planning in the ear-nose-throat region • Aiding comparisons of different treatment options • Aiding treatment planning for oral appliances

Source page: https://510kreport.com/device/K152661
Methodology: https://510kreport.com/methodology