PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM— 510(k) K964485

Substantially Equivalent

Eliav , Ltd.

FDA 510(k) clearance K964485 for PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM, Substantially Equivalent on 1997-02-04. Applicant: Eliav , Ltd..

Clearance details

Applicant: Eliav , Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1996-11-08
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, IL

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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.