PhoeniX— 510(k) K192011

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K192011 for PhoeniX, Substantially Equivalent on 2019-09-25. Applicant: Sedecal., Sa..

Clearance details

Applicant: Sedecal., Sa.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2019-07-29
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Algete, ES

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.