# K091752: Viztek WL

- Pathway: 510(k) (Traditional)
- Applicant: Viztek, Inc.
- Decided: Nov 12, 2009 after 149 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082604: Viztek DR, Models: DR1000, DR3000, DR4000, Viztek, Inc. (2008) Summary page 1.
- K090625: Wireless Portable Detector FD-W17, Philips Medical Systems North America Co. (2009) Summary page 1.
- K003438: Smart Rad, Cmt Medical Technologies, Ltd. (2001) Summary page 1.

## 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. Excludes fluoroscopy, angiography, and mammography.

Source page: https://510kreport.com/device/K091752
Methodology: https://510kreport.com/methodology