# K080582: Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA

- Pathway: 510(k) (Traditional)
- Applicant: Medicatech USA
- Decided: May 15, 2008 after 73 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: 5 generations back to K981556 (1998). 11 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062335: Sedecal X Plus LP Plus, Sedecal., Sa. (2006) Summary page 1.
- K080064: Flaatz 750, Drtech Corp. (2008) Summary page 1.
- K042876: Urs LP Digital, Millennium, Radpro, Sedecal., Sa. (2004) Summary page 1.

## Most influential descendants
- K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System (2011), 14 descendants of its own
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T (2013), 11 descendants of its own
- K140825: Delworks DR System (2014), 7 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own
- K192541: DigiX FDX (2019), 5 descendants of its own

## Indications for use
The DDR Digital X-Ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Source page: https://510kreport.com/device/K080582
Methodology: https://510kreport.com/methodology