# K032546: Hologic DR Imagepro

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Oct 16, 2003 after 59 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
Longest line of descent: 4 generations back to K945188 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990241: Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip, Accuimage Diagnostics Corp. (1999) Summary page 1.

## Indications for use
The Hologic DR ImagePro is a Windows-based software application acting as a Picture Archiving and Communications System (PACS). It is intended to be used by clinical professionals to view, manipulate, transmit, print, and store DICOM compliant digital radiographic image data. It provides standard tools for image zoom, rotation, enhancement, smoothing, and sharpening. Hologic DR ImagePro also provides software tools for merging two to five DICOM image files of an individual patient together to aid visualization of large areas of interest. The software assists users in merging, or "stitching," the separate images together manually and allows users to draw lines and angles within the images to obtain measurements. The software runs on standard, off-the-shelf PC components.

Source page: https://510kreport.com/device/K032546
Methodology: https://510kreport.com/methodology