# K200018: HAD1717MC

- Pathway: 510(k) (Traditional)
- Applicant: H&Abyz
- Decided: Jan 31, 2020 after 28 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: 7 generations back to K862120 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152094: GR40CW, Samsung Electronics Co., Ltd. (2015) Summary page 4.

## Indications for use
Digital Flat Panel X-ray Detector, HAD1717MC is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K200018
Methodology: https://510kreport.com/methodology