# K082604: Viztek DR, Models: DR1000, DR3000, DR4000

- Pathway: 510(k) (Traditional)
- Applicant: Viztek, Inc.
- Decided: Nov 21, 2008 after 74 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). 9 ancestors in all.
41 later devices descend from it; 3 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042876: Urs LP Digital, Millennium, Radpro, Sedecal., Sa. (2004) Summary page 1.
- K003438: Smart Rad, Cmt Medical Technologies, Ltd. (2001) Summary page 1.

## Most influential descendants
- K102123: Vizion DR (2011), 36 descendants of its own
- K112661: Vizion DR (2011), 34 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

## Indications for use
This Digital Radiographic System is 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/K082604
Methodology: https://510kreport.com/methodology