Intelli-C

Interventional Fluoroscopic X-ray System

NRT X-ray A/S

The following data is part of a premarket notification filed by Nrt X-ray A/s with the FDA for Intelli-c.

Pre-market Notification Details

• Device ID: K173631
• 510k Number: K173631
• Device Name: Intelli-C
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: NRT X-ray A/S Birkegaardsvej 16 Hasselager, DK 8361
• Contact: Jan Malling
• Correspondent: Kevin Walls; Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-24
• Decision Date: 2018-07-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05713464000541	K173631	000
05713464000411	K173631	000
05713464000565	K173631	000
05713464000374	K173631	000
05713464000305	K173631	000
05713464000350	K173631	000
05713464000398	K173631	000
05713464000428	K173631	000
05713464000435	K173631	000
05713464000442	K173631	000
05713464000459	K173631	000
05713464000312	K173631	000
05713464000329	K173631	000
05713464000336	K173631	000
05713464000343	K173631	000
05713464000381	K173631	000
05713464000404	K173631	000
05713464000527	K173631	000
05713464000756	K173631	000