DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA— 510(k) K093640

Name: FDA 510(k) clearance K093640
Creator: U.S. Food and Drug Administration
Published: 2011-04-29

Substantially Equivalent

Electron Jsco.

FDA 510(k) clearance K093640 for DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA, Substantially Equivalent on 2011-04-29. Applicant: Electron Jsco.. Device class: 2.

Clearance details

Applicant: Electron Jsco.
Product code: Code IXK
Device class: Class 2
Regulation: 21 CFR 892.1630
Advisory panel: Radiology
Date received: 2009-11-24
Decision date: 2011-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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