SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS— 510(k) K090238

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K090238 for SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS, Substantially Equivalent on 2009-02-27. Applicant: Sedecal., Sa..

Clearance details

Applicant: Sedecal., Sa.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2009-02-02
Decision date: 2009-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Deerfield, IL, US

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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.