MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)— 510(k) K012289

Substantially Equivalent

Elekta Oncology Systems, Ltd.

FDA 510(k) clearance K012289 for MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID), Substantially Equivalent on 2001-08-14. Applicant: Elekta Oncology Systems, Ltd..

Clearance details

Applicant: Elekta Oncology Systems, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2001-07-20
Decision date: 2001-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Norcross, GA, US

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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.