DEFINIUM 5000 X-RAY SYSTEM— 510(k) K063283

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K063283 for DEFINIUM 5000 X-RAY SYSTEM, Substantially Equivalent on 2006-11-17. Applicant: Sedecal., Sa.. Device class: 2.

Clearance details

Applicant: Sedecal., Sa.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2006-10-30
Decision date: 2006-11-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.