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Lantis Treatstation

by Siemens Medical Solutions USA, Inc.

510(k) K972275

Lantis Treatstation is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K972275 on 8 Sep 1997, active as of 22 Oct 2026. 5 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

5 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 NumberK972275 Date8 Sep 1997ClearedStatusActive

Official records

Recalls

5 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2195-2019 FDA Class II initiated 10 Jul 2019
    • Terminated Z-2197-2019 FDA Class II initiated 10 Jul 2019
    • Terminated Z-2196-2019 FDA Class II initiated 10 Jul 2019

    Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability

    • Terminated Z-1282-2015 FDA Class II initiated 21 Jan 2015

    There is a potential safety risk when using LANTIS server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment to the patient.

    • Terminated Z-1840-2014 FDA Class II initiated 6 May 2014

    There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and LANTIS database corruption.

Timeline

6 dated events

  1. Cleared FDA 510(k) K972275
  2. Recall initiated FDA recalls Z-1840-2014
  3. Recall initiated FDA recalls Z-1282-2015
  4. Recall initiated FDA recalls Z-2195-2019
  5. Recall initiated FDA recalls Z-2197-2019
  6. Recall initiated FDA recalls Z-2196-2019

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  • Withdrawn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

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

Cited by

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

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

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