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Artiste Solution with SYS_VB50 Update

by Siemens Medical Solutions USA, Inc.

510(k) K103606

Artiste Solution with SYS_VB50 Update is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K103606 on 15 Apr 2011, 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

None ongoing

7 closed

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 NumberK103606 Date15 Apr 2011ClearedStatusActive

Official records

Recalls

7 recalls · FDA

    • Terminated Z-1677-2020 FDA Class II initiated 18 Feb 2020

    Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

    • Terminated Z-2876-2016 FDA Class II initiated 26 Jul 2016

    Software patch installation to address several safety issues.

    • Terminated Z-2812-2015 FDA Class II initiated 5 Aug 2015

    A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

    • Terminated Z-1182-2013 FDA Class II initiated 4 Apr 2013

    Software update to fix multiple safety related issues.

    • Terminated Z-2073-2012 FDA Class II initiated 25 Jun 2012

    Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.

    • Terminated Z-1486-2012 FDA Not yet classified initiated 3 Apr 2012

    SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.

    • Terminated Z-0462-2012 FDA Unclassified (pre-2012) initiated 2 Nov 2011

    The software release will bring current Installed Base system to the forward production version. It is a result of the final system testing addressing several safety issues that are not critical for the safe use of the device and multiple performance defects.

Timeline

8 dated events

  1. Cleared FDA 510(k) K103606
  2. Recall initiated FDA recalls Z-0462-2012
  3. Recall initiated FDA recalls Z-1486-2012
  4. Recall initiated FDA recalls Z-2073-2012
  5. Recall initiated FDA recalls Z-1182-2013
  6. Recall initiated FDA recalls Z-2812-2015
  7. Recall initiated FDA recalls Z-2876-2016
  8. Recall initiated FDA recalls Z-1677-2020

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
IYE
Device class
Class II
Regulation
21 CFR Part 892.5050
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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