# K183422: Wireless Digital Flat Panel Detector

- Pathway: 510(k) (Special)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Jan 9, 2019 after 30 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)
- K182550: Wireless Digital Flat Panel Detector, Iray Technology Taicang, Ltd. (2018) Summary page 5.

## Indications for use
Mars1717XF-GSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. We understand the Agency has become aware of situations where solid state detectors inserted into radiographic systems adversely impacted device performance due to improper integration (reference:http://www.fda.gov/downloads/MedicalDevices/ResourcesforY ou/Industry/UCM385149.pdf ). Below is a summary of the information from the Mars1717XF-GSI user manuals covering key electromechanical and computer requirements needed for X-ray system interface and integration. 1. Mechanical interface requirements. 2. Computer requirements 3. Data communication interface requirements 4. Electrical power requirements 5. X-ray trigger interface requirements Neither the Mars1717XF-GSI detector nor its software act as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements.

Source page: https://510kreport.com/device/K183422
Methodology: https://510kreport.com/methodology