Cedara Webaccess, Model: 2.4

510(k) K092915

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK092915	Date23 Jun 2010Cleared	StatusActive

4 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-0611-2017 FDA Class II initiated 25 May 2016
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
2 recalls, same reason
- Terminated Z-2531-2016 FDA Class II initiated 30 Jan 2016
- Terminated Z-2532-2016 FDA Class II initiated 30 Jan 2016
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.

1 jurisdiction

United States — FDA 510(k) Active

510(k)