# K023467: HCP Dicom Net

- Pathway: 510(k) (Traditional)
- Applicant: Softlink International, Inc.
- Decided: Jan 7, 2003 after 83 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 K914525 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954159: Digital Imaging System, Camtronics, Ltd. (1996) Summary page 1.
- K964274: Writestar, and Viewstar, Comview Corp. (1997) Summary page 1.
- (no number) TCS-Telecardiology System: named in the summary without a submission number

## Indications for use
HCP DICOM Net is a software device intended to acquire and store medical images studies from catheterization laboratories, Echo cardiograms, CT & MRI and other such modalities. In addition, HCP DICOM Net provides image enhancement and filtering tools for viewing of selected images. It also imports image studies from DICOM CDWDVD's, makes copies of image studies and converts and exports image studies into DICOM3 and other commercial file formats. HCP DICOM Net also integrates industry standard third party approved software within its application to allow for analysis of the acquired image.

Source page: https://510kreport.com/device/K023467
Methodology: https://510kreport.com/methodology