# K181526: XRpad2 4343 HWC-M Flat Panel Detector

- Pathway: 510(k) (Special)
- Applicant: Varex Imaging Corporation
- Decided: Jul 3, 2018 after 22 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: 9 generations back to K981556 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161966: PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector, Perkinelmer, Inc. (2016) Summary page 4.

## Indications for use
The XRpad2 4343 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

Source page: https://510kreport.com/device/K181526
Methodology: https://510kreport.com/methodology