# K192512: Focus 35C Detector, Trimax 35C Detector

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Oct 16, 2019 after 34 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K981556 (1998). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182551: Wireless Digital Flat Panel Detector, Iray Technology Taicang, Ltd. (2018) Summary page 6.

## Indications for use
Focus 35C and TRIMAX 35C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. There are no differences between the 2 models except the model name and trade mark.

Source page: https://510kreport.com/device/K192512
Methodology: https://510kreport.com/methodology