# K201503: Edge Air (1417) Digital Flat Panel X-ray Detector

- Pathway: 510(k) (Special)
- Applicant: Osko, Inc.
- Decided: Jun 29, 2020 after 24 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: 8 generations back to K981556 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172681: Edge Air Digital Flat Panel X-ray Detector, Osko, Inc. (2017) Summary page 4.

## Indications for use
Edge Air(1417) Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.

Source page: https://510kreport.com/device/K201503
Methodology: https://510kreport.com/methodology