iViewDose R1.0— 510(k) K153011

Name: FDA 510(k) clearance K153011
Creator: U.S. Food and Drug Administration
Published: 2015-12-11

Substantially Equivalent

Elekta Limited

FDA 510(k) clearance K153011 for iViewDose R1.0, Substantially Equivalent on 2015-12-11. Applicant: Elekta Limited. Device class: 2.

Clearance details

Applicant: Elekta Limited
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2015-10-14
Decision date: 2015-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crawley, 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 →

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