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ARTIS icono

by Siemens Medical Solutions USA, Inc. 2 variants

510(k) K190768

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190768 Date12 Sep 2019ClearedStatusActive

Official records

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-0956-2023 FDA Class II initiated 16 Dec 2022

    Mechanical connection between the tabletop and table base may be lost.

  • 2 recalls, same reason

    • Ongoing Z-1245-2022 FDA Class II initiated 11 Apr 2022
    • Ongoing Z-1246-2022 FDA Class II initiated 11 Apr 2022

    if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

    • Ongoing Z-1339-2022 FDA Class II initiated 25 Feb 2022

    After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.

Timeline

5 dated events

  1. Cleared FDA 510(k) K190768
  2. Recall initiated FDA recalls Z-1339-2022
  3. Recall initiated FDA recalls Z-1245-2022
  4. Recall initiated FDA recalls Z-1246-2022
  5. Recall initiated FDA recalls Z-0956-2023

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

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

The ARTIS icono is an interventional fluoroscopic X-ray system, classified as a Class II device under FDA regulations (21 CFR 892.1650). It provides real-time imaging for complex interventions in interventional radiology, cardiovascular care, and neurointerventions, featuring high-resolution 2K imaging and precise mechanical flexibility. The system supports anatomical navigation and semi-automatic identification of feeder vessels, enhancing procedural accuracy.

This system is designed for use in interventional radiology suites, hybrid operating rooms, and cardiovascular laboratories. It is a reusable medical device requiring proper sterilization and maintenance. The ARTIS icono holds a 510(k) clearance (K190768) for substantial equivalence and is available in multiple configurations, as indicated by the associated registration numbers. It adheres to FDA regulatory standards for interventional fluoroscopic X-ray systems.

ARTIS icono

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