510(k) · Cleared
Recalled · Class II · 2019Lantis Treatstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYE Accelerator, Linear, Medical
Cleared on Sep 8, 1997 as substantially equivalent to K913612 (Impac Medical Systems, Inc., 1991) after an 82-day review. Its family tree reaches back 1 generation to 1991. 20 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 8, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913612 (1991). 20 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913612 SequencerImpac Medical Systems, Inc. · 1991
- This deviceK972275 Lantis TreatstationSiemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 16 of its ownK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 13 of its ownK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 11 of its ownK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK082775 Prescision OptionSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK090683 Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · cites it directly16descendants
- K060226Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on13descendants
- K072485Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · 3 generations on11descendants
- K082775Prescision OptionSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on9descendants
- K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913612 | Sequencer | Impac Medical Systems, Inc. | 1991 | — |
| 0 (this device) | K972275 | Lantis Treatstation | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| +2 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| +3 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| +3 | K082775 | Prescision Option | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K090683 | Syngo RT Therapist Connect | Siemens Medical Solutions USA, Inc. | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913612 | SequencerSummary page 1…rd and Verify Radiation Treatment System 21 CFR § 892.5710 Class II, Product Code: RA 90 IYE Classification Names: Predicate Device: Impac Medical Systems’ Sequencer (K913612) Description of Device: LANTIS TREATSTATION is a direct replacement for the sequencing/VMI module of the Impac Sequencer Record… | 1991 |
What descends from it? (20)
See all 202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2019 | Class II | Z-2197-2019 | Other | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability |
| Jul 10, 2019 | Class II | Z-2195-2019 | Other | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability |
| Jul 10, 2019 | Class II | Z-2196-2019 | Other | Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability |
| Jan 21, 2015 | Class II | Z-1282-2015 | Use error | 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 | Use error | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K031764 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 16 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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…
Read the full statement (126 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972275: Lantis Treatstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972275
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026