DESKTOP PRO— 510(k) K080585

Name: FDA 510(k) clearance K080585
Creator: U.S. Food and Drug Administration
Published: 2008-06-11

Substantially Equivalent

Elekta , Ltd.

FDA 510(k) clearance K080585 for DESKTOP PRO, Substantially Equivalent on 2008-06-11. Applicant: Elekta , Ltd.. Device class: 2.

Clearance details

Applicant: Elekta , Ltd.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2008-03-03
Decision date: 2008-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sussex, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K080585

K-number listed on FDA's recall record

Z-1082-2014 — Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.Class II·Terminated·Elekta, Inc.·20131125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080585.

Data sourced from openFDA. This site is unofficial and independent of the FDA.