IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW— 510(k) K981790

Substantially Equivalent

Elekta Oncology Systems, Ltd.

FDA 510(k) clearance K981790 for IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW, Substantially Equivalent on 1998-08-07. Applicant: Elekta Oncology Systems, Ltd..

Clearance details

Applicant: Elekta Oncology Systems, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1998-05-20
Decision date: 1998-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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.