# K241346: IODR1717 / IODR1417 / IODR1417-GF  (Digital Flat Panel X-ray Detector)

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Imaging Healthcare, Inc.
- Decided: Nov 7, 2024 after 178 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: 20 generations back to K981556 (1998). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223930: A1417MCW/A1717MCW/F1417MCW, H&abyz Co., Ltd. (2023) Summary page 7.

## Indications for use
The IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-Ray Detector) is indicated as a digital imaging solution designed for providing the general radiographic diagnosis of human anatomy targeting both adults and children. It is intended to replace film-based radiographic diagnostic systems. Not to be used for mammography.

Source page: https://510kreport.com/device/K241346
Methodology: https://510kreport.com/methodology