# K091288: Medi-6000 Medical Image Digitizer

- Pathway: 510(k) (Traditional)
- Applicant: Microtek International, Inc.
- Decided: Aug 14, 2009 after 105 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933632 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021949: Fulcrum, Howtek, Inc. (2002) Summary page 1.
- K993597: PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617, Vidar Systems Corp. (1999) Summary page 1.

## Indications for use
The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. This device is not to be used for primary image diagnosis in mammography. The target users of the device are medical professionals or trained staffs.

Source page: https://510kreport.com/device/K091288
Methodology: https://510kreport.com/methodology