Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems— 510(k) K203537

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K203537 for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems, Substantially Equivalent on 2021-02-01. Applicant: Sedecal., Sa..

Clearance details

Applicant: Sedecal., Sa.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2020-12-03
Decision date: 2021-02-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Algete, ES

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.