HELAX-VISIR— 510(k) K972617

Substantially Equivalent

Helax AB

FDA 510(k) clearance K972617 for HELAX-VISIR, Substantially Equivalent on 1997-10-01. Applicant: Helax AB.

Clearance details

Applicant: Helax AB
Product code: Code IYE
Advisory panel: Radiology
Date received: 1997-07-09
Decision date: 1997-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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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.