COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D— 510(k) K090171

Name: FDA 510(k) clearance K090171
Creator: U.S. Food and Drug Administration
Published: 2009-04-30

Substantially Equivalent

E-Woo Technology

FDA 510(k) clearance K090171 for COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D, Substantially Equivalent on 2009-04-30. Applicant: E-Woo Technology. Device class: 2.

Clearance details

Applicant: E-Woo Technology
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2009-01-23
Decision date: 2009-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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