# K080064: Flaatz 750

- Pathway: 510(k) (Traditional)
- Applicant: Drtech Corp.
- Decided: Jan 23, 2008 after 13 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: 1 generation back to K063710 (2007). 1 ancestor in all.
69 later devices descend from it; 8 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063710: Saturn 9000, New Medical Co., Ltd. (2007). Our OCR of the scanned summary read K083710, FDA’s number for Retractor Lite (Thomas Surgical Instruments, Inc.), decided Feb 23, 2009, after this device. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.

## Most influential descendants
- K113812: ATAL-8 (2012), 41 descendants of its own
- 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

## Indications for use
The FLAATZ 750 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/K080064
Methodology: https://510kreport.com/methodology