510(k) · Cleared
ClearedAlignRT Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Rt, Ltd. · IYE Accelerator, Linear, Medical
Cleared on Mar 4, 2021 as substantially equivalent to K193431 (Vision Rt, Ltd., 2020) after a 106-day review. Its family tree reaches back 7 generations to 1987. 5 later devices descend from it.
- Decided
- Mar 4, 2021
- Review
- 106 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K864886 (1987). 10 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 6 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 5 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 4 generations backK072171 Gatect-RTVision RT Limited · 2007
- 3 generations backK123371 Alignrt PlusVision RT Limited · 2013 · Recalled
- 2 generations backK181218 AlignRT PlusVision Rt, Ltd. · 2018
- 1 generation backK193431 AlignRT PlusVision Rt, Ltd. · 2020
- This deviceK203387 AlignRT PlusVision Rt, Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK212583 AlignRT PlusVision Rt, Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK233622 AlignRT PlusVision Rt, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK253004 LUNA 3DLap GmbH Laser Applikationen · 2026
- Descendant · 3 generations on · 0 of its ownK253012 AlignRT Plus (8.0)Vision Rt, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232031 LUNA 3DLap GmbH Laser Applikationen · 2024
Most influential descendants
Showing 5 of 5 · See all- K212583AlignRT PlusVision Rt, Ltd. · 2021 · cites it directly4descendants
- K233622AlignRT PlusVision Rt, Ltd. · 2024 · 2 generations on2descendants
- K253004LUNA 3DLap GmbH Laser Applikationen · 2026 · 3 generations on0descendants
- K253012AlignRT Plus (8.0)Vision Rt, Ltd. · 2026 · 3 generations on0descendants
- K232031LUNA 3DLap GmbH Laser Applikationen · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −6 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −5 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −4 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| −3 | K123371 | Alignrt Plus | Vision RT Limited | 2013 | 5 |
| −2 | K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018 | — |
| −1 | K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020 | — |
| 0 (this device) | K203387 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| +1 | K212583 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| +2 | K233622 | AlignRT Plus | Vision Rt, Ltd. | 2024 | — |
| +3 | K253004 | LUNA 3D | Lap GmbH Laser Applikationen | 2026 | — |
| +3 | K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | 2026 | — |
| +2 | K232031 | LUNA 3D | Lap GmbH Laser Applikationen | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K193431 | AlignRT PlusSummary page 4…Date Summary was prepared: 17 December 2020 PREDICATE DEVICE INFORMATION: Name of the Device: AlignRT Plus Premarket Notification: K193431 Trade/Proprietary Name: AlignRT Plus (incorporating AlignRT, GateCT, GateRT), may be brande… | 2020 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212583 | AlignRT Plus | 2021 | 4 |
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 34 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K212583 (Vision Rt, Ltd., 2021) has gone furthest, with 4 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. 2021, 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 AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient’s respiratory pattern for respiratory synchronized…
Read the full statement (151 words)
The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations.
AlignRT Plus is also used to track the patient’s respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment.
Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning.
AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch.
AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
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/K203387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203387: AlignRT Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203387
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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