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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K062386
FOIA Releasable 510(k) K062386
Device Name QANGIO CT
Applicant
Medis Medical Imaging Systems BV
9 Schuttersveld
Leiden,  NL 2316 XG
Applicant Contact J.I. HOLLANDER
Correspondent
Medis Medical Imaging Systems BV
9 Schuttersveld
Leiden,  NL 2316 XG
Correspondent Contact J.I. HOLLANDER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/15/2006
Decision Date 10/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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