# K031372: Personal Digital Workstation (PDW); Film Digitizing Camera and Digital Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Maxxvision, LLC
- Decided: Jul 2, 2003 after 63 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The hand-held device is intended to provide better visualization of mammographic films for review by radiologists. A portion of the film image is digitized, processed, and displayed in real-time as a magnified view on an adjacent monitor.

Source page: https://510kreport.com/device/K031372
Methodology: https://510kreport.com/methodology