TheraView TBI— 510(k) K170058

Substantially Equivalent

Cablon Medical B.V.

FDA 510(k) clearance K170058 for TheraView TBI, Substantially Equivalent on 2017-03-03. Applicant: Cablon Medical B.V..

Clearance details

Applicant: Cablon Medical B.V.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2017-01-06
Decision date: 2017-03-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Leusden, NL

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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.