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Cedara I-Softview

by Cedara Software Corp.

510(k) K022881

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK022881 Date22 Oct 2002ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2601-2017 FDA Class II initiated 24 May 2017

    Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

    • Terminated Z-0878-2017 FDA Class II initiated 8 Oct 2015

    Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.

    • Terminated Z-1243-2007 FDA Unclassified (pre-2012) initiated 23 Aug 2007

    Defects in the Auto Launch functionality make it possible for a mismatch of patient data.

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  • Withdrawn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

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