510(k) · Cleared
ClearedThales 3D Mr Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lap GmbH Laser Applikationen · IYE Accelerator, Linear, Medical
Cleared on Jun 3, 2020 as substantially equivalent to K191646 (Ptw-Freiburg Physikalisch-Technische-Werkstaetten, 2020) after a 58-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 3, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954165 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK954165 PTW-MP3 & PTW-MP3S Automatic Water PhantomPtw-New York Corp. · 1995
- 2 generations backK161807 BeamscanPtw-Freiburg Physikalisch Technische-Werksraetten · 2017
- 1 generation backK191646 Beamscan MRPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2020
- This deviceK200907 Thales 3D Mr ScannerLap GmbH Laser Applikationen · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954165 | PTW-MP3 & PTW-MP3S Automatic Water Phantom | Ptw-New York Corp. | 1995 | — |
| −2 | K161807 | Beamscan | Ptw-Freiburg Physikalisch Technische-Werksraetten | 2017 | — |
| −1 | K191646 | Beamscan MR | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2020 | — |
| 0 (this device) | K200907 | Thales 3D Mr Scanner | Lap GmbH Laser Applikationen | 2020 | — |
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 |
|---|---|---|---|
| * | K191646 | Beamscan MRSummary page 5…imaging and a magnetic field of less than or equal to 0.35 tesla. Predicate device: Device Name: BEAMSCAN MR 510k number: K191646 Device Classification Name: Medical charged-particle radiation therapy system Product Code: IYE C.F… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 THALES 3D MR SCANNER system is designed to measure the characteristic radiation beam for an irradiation unit. The beam data is stored in the software program and can be exported from there for use during commissioning in a treatment planning system (TPS) or for quality assurance. The THALES 3D MR SCANNER system can be used with irradiation units with integrated magnetic resonance imaging and a magnetic field of less than or equal to 0.35 tesla.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200907: Thales 3D Mr Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200907
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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