# K072960: CDP 5000, Media and Distribution Center, Diagnet

- Pathway: 510(k) (Traditional)
- Applicant: Cdp, Ltd.
- Decided: Nov 8, 2007 after 20 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K896095 (1990). 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)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.

## Recalls of this device
- Apr 2, 2014 · Class II · Z-1495-2014: Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
- Sep 1, 2011 · Not classified · Z-0032-2012: Clinical measurements on true size printouts may be inaccurate

## Indications for use
The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Users of CDP 5000 can perform the following tasks: * Query and retrieve images from the CDP 5000 Archive, using any third party workstation capable of performing DICOM query/retrieve functions. * Use DIAGNET network viewer to search, retrieve and manipulate patient images. • Create DICOM compliant portable media (i.e. CD-R) containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application. Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking; measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting). Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians, technologist, and others.

Source page: https://510kreport.com/device/K072960
Methodology: https://510kreport.com/methodology