# K102285: Krystalrad (ATAL8)

- Pathway: 510(k) (Traditional)
- Applicant: Medicatech USA
- Decided: Jan 3, 2011 after 144 days
- Product code: KPR (System, X-Ray, Stationary)
- 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The KrystalRAD (ATALS) Digital X-Ray Systems 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/K102285
Methodology: https://510kreport.com/methodology