# K972275: Lantis Treatstation

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 8, 1997 after 82 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913612 (1991). 1 ancestor in all.
20 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913612: Sequencer, Impac Medical Systems, Inc. (1991) Summary page 1.

## Most influential descendants
- K031764: Oncor Avant-Garde with Coherence Workspaces (2003), 16 descendants of its own
- K060226: Oncor Expression (2006), 13 descendants of its own
- K072485: Artiste MV SA (2007), 11 descendants of its own
- K082775: Prescision Option (2009), 9 descendants of its own
- K090683: Syngo RT Therapist Connect (2009), 7 descendants of its own

## Recalls of this device
- Jul 10, 2019 · Class II · Z-2197-2019: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
- Jul 10, 2019 · Class II · Z-2195-2019: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
- Jul 10, 2019 · Class II · Z-2196-2019: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
- Jan 21, 2015 · Class II · Z-1282-2015: 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.
- May 6, 2014 · Class II · Z-1840-2014: 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 

## Indications for use
The intended use of the LANTIS TREATSTATION is to allow the radiation therapist to deliver treatment to the patient using the MEVATRON and all available accessories. This entails selecting a patient, selecting today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, LANTIS TREATSTATION supports intensity modulation (IM), a process of shaping, modifying, and moving the beam around a target to maximize the dose at the target and minimize the dose to all normal structures. The intended use is the same as the predicate device.

Source page: https://510kreport.com/device/K972275
Methodology: https://510kreport.com/methodology