# K100703: Stationary X-Ray System (Detector) Model: Altas

- Pathway: 510(k) (Traditional)
- Applicant: Comed Co., Ltd.
- Decided: Dec 21, 2010 after 284 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: 2 generations back to K973710 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061595: Xaminer, Imaging Dynamics Company, Ltd. (2006) Summary page 1.
- K073056: Digital Radiography System, Model: QXR-9, Vieworks Co., Ltd. (2007) Summary page 1.

## Indications for use
The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Atlas is not intended for mammography.

Source page: https://510kreport.com/device/K100703
Methodology: https://510kreport.com/methodology