# K113812: ATAL-8

- Pathway: 510(k) (Traditional)
- Applicant: Atlaim
- Decided: May 3, 2012 after 132 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 K063710 (2007). 2 ancestors in all.
41 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080064: Flaatz 750, Drtech Corp. (2008) Summary page 1.

## Most influential descendants
- K123644: Vizion + DR (2013), 33 descendants of its own
- K152279: ViZion DR + Wireless (2015), 27 descendants of its own
- K161730: Wireless Digital Flat Panel Detector (2016), 24 descendants of its own
- K182551: Wireless Digital Flat Panel Detector (2018), 18 descendants of its own
- K183713: Wireless Digital Flat Detector (2019), 9 descendants of its own

## Indications for use
The ATAL 8 and ATAL 8c is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

Source page: https://510kreport.com/device/K113812
Methodology: https://510kreport.com/methodology