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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K173631
Device Name Intelli-C
Applicant
NRT X-ray A/S
Birkegaardsvej 16
Hasselager,  DK 8361
Applicant Contact Jan Malling
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received11/24/2017
Decision Date 07/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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