# K200622: Focus 43C detector, TRIMAX 43C detector

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Apr 1, 2020 after 23 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: 13 generations back to K981556 (1998). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183713: Wireless Digital Flat Detector, Iray Technology Taicang, Ltd. (2019) Summary page 6.

## Indications for use
Focus 43C and TRIMAX 43C 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. These two devices are not intended for mammography, dental applications There are no differences between the 2 models except the model name and trade mark.

Source page: https://510kreport.com/device/K200622
Methodology: https://510kreport.com/methodology