# K132842: Flaatz 600 Series (Flaatz 600/601)

- Pathway: 510(k) (Special)
- Applicant: Drtech Corp.
- Decided: Feb 21, 2014 after 164 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: 4 generations back to K063710 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111583: Flaatz 560, Drtech Corp. (2011) Summary page 1.

## Indications for use
The FLAATZ 600 Series (FLAATZ 600/601) is indicated for use in generating 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/K132842
Methodology: https://510kreport.com/methodology