# K082798: Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000

- Pathway: 510(k) (Special)
- Applicant: Medicatech USA
- Decided: Oct 28, 2008 after 35 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: 6 generations back to K981556 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080582: Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA, Medicatech USA (2008) Summary page 1.

## Indications for use
The MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). (Digital Diagnostic X-Ray Systems) are intendcd for use by a qualified/trained doctor or technician on both adult and pediatric subjccts 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/K082798
Methodology: https://510kreport.com/methodology