# K973081: Digitizer Director: Image Compression Module (HO4059-Rev 2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Howtek, Inc.
- Decided: Nov 5, 1997 after 79 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: 2 generations back to K896095 (1990). 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)
- K962699: Radworks Medical Imaging Software, Applicare Medical Imaging, B.V. (1996) Summary page 1.

## Indications for use
The intended use of DIGITIZER DIRECTOR: Image Compression Module is as a DICOM image compressor that will enable any hospital or medical facility PC with adequate memory and the appropriate film digitizer to send images to other DICOM entities such as viewing stations and databases in an efficient manner. The compression algorithms used are fully supported by the DICOM 3.0 Standard.

Source page: https://510kreport.com/device/K973081
Methodology: https://510kreport.com/methodology