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Artis One

by Siemens Medical Solutions USA, Inc.

510(k) K133580

Artis One is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K133580 on 28 Apr 2014, active as of 22 Oct 2026. 7 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 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 NumberK133580 Date28 Apr 2014ClearedStatusActive

Official records

Recalls

7 recalls · 2 ongoing · FDA

    • Ongoing Z-0922-2025 FDA Class II initiated 2 Jan 2025

    A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.

    • Ongoing Z-1469-2023 FDA Class II initiated 21 Mar 2023

    Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

    • Terminated Z-0298-2021 FDA Class II initiated 21 Sep 2020

    Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).

    • Terminated Z-1148-2018 FDA Class II initiated 12 Jan 2018

    Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.

    • Terminated Z-0614-2018 FDA Class II initiated 22 Aug 2017

    The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

    • Terminated Z-1282-2016 FDA Class II initiated 11 Mar 2016

    After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.

    • Terminated Z-1119-2015 FDA Class II initiated 16 Jan 2015

    The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

Timeline

8 dated events

  1. Cleared FDA 510(k) K133580
  2. Recall initiated FDA recalls Z-1119-2015
  3. Recall initiated FDA recalls Z-1282-2016
  4. Recall initiated FDA recalls Z-0614-2018
  5. Recall initiated FDA recalls Z-1148-2018
  6. Recall initiated FDA recalls Z-0298-2021
  7. Recall initiated FDA recalls Z-1469-2023
  8. Recall initiated FDA recalls Z-0922-2025

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

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