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Intelli-C

by Nrt X-Ray A/S

510(k) K173631

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173631 Date11 Jul 2018ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-1784-2024 FDA Class II initiated 17 Apr 2024

    X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.

  • 2 recalls, same reason

    • Ongoing Z-1669-2023 FDA Class II initiated 27 Apr 2023
    • Ongoing Z-1668-2023 FDA Class II initiated 27 Apr 2023

    There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.

    • Ongoing Z-0526-2022 FDA Class II initiated 21 Jan 2022

    Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Intelli-C is an Interventional Fluoroscopic X-Ray System. It is a multipurpose tilt-C X-ray system designed for diagnostic and interventional procedures.

The device is supplied as a reusable system for use in radiology settings. It received FDA 510(k) clearance (K173631) as substantially equivalent to a predicate device.

Other devices from Nrt X-Ray A/S