# K213497: ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)

- Pathway: 510(k) (Special)
- Applicant: H&abyz Co., Ltd.
- Decided: Nov 15, 2021 after 14 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: 18 generations back to K981556 (1998). 84 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203188: ADD, H&abyz Co., Ltd. (2021) Summary page 6.

## Most influential descendants
- K223930: A1417MCW/A1717MCW/F1417MCW (2023), 1 descendant of its own
- K241346: IODR1717 / IODR1417 / IODR1417-GF  (Digital Flat Panel X-ray Detector) (2024), 0 descendants of its own

## Indications for use
ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used for mammography.

Source page: https://510kreport.com/device/K213497
Methodology: https://510kreport.com/methodology