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Cdp 5000, Media and Distribution Center, Diagnet

by Cdp, Ltd.

510(k) K072960

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072960 Date8 Nov 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1495-2014 FDA Class II initiated 2 Apr 2014

    Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations

    • Terminated Z-0032-2012 FDA Unclassified (pre-2012) initiated 1 Sep 2011

    Clinical measurements on true size printouts may be inaccurate

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent