510(k) · Cleared
ClearedAlignRT Plus (8.0)
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 18, 2026 as substantially equivalent to K233622 (Vision Rt, Ltd., 2024) after a 180-day review. Its family tree reaches back 10 generations to 1987.
- Decided
- Mar 18, 2026
- Review
- 180 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K864886 (1987). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 6 generations between
- 3 generations backK203387 AlignRT PlusVision Rt, Ltd. · 2021
- 2 generations backK212583 AlignRT PlusVision Rt, Ltd. · 2021
- 1 generation backK233622 AlignRT PlusVision Rt, Ltd. · 2024
- This deviceK253012 AlignRT Plus (8.0)Vision Rt, Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 9 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 8 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 7 generations backK072171 Gatect-RTVision RT Limited · 2007
- 6 generations backK123371 Alignrt PlusVision RT Limited · 2013 · Recalled
- 5 generations backK181218 AlignRT PlusVision Rt, Ltd. · 2018
- 4 generations backK193431 AlignRT PlusVision Rt, Ltd. · 2020
- 3 generations backK203387 AlignRT PlusVision Rt, Ltd. · 2021
- 2 generations backK212583 AlignRT PlusVision Rt, Ltd. · 2021
- 1 generation backK233622 AlignRT PlusVision Rt, Ltd. · 2024
- This deviceK253012 AlignRT Plus (8.0)Vision Rt, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −9 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −8 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −7 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| −6 | K123371 | Alignrt Plus | Vision RT Limited | 2013 | 5 |
| −5 | K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018 | — |
| −4 | K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020 | — |
| −3 | K203387 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| −2 | K212583 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| −1 | K233622 | AlignRT Plus | Vision Rt, Ltd. | 2024 | — |
| 0 (this device) | K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K233622 | AlignRT PlusSummary page 5…9/19/2025 Primary Predicate device information Device name: AlignRT Plus Premarket notification: K233622 Manufacturer: Vision RT Limited Common name: Surface-guide… | 2024 |
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 39 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K233622.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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: * Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep- Inspiration Breath Hold (DIBH). * Verification of patient identity for their radiation treatment session. * Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment…
Read the full statement (127 words)
The AlignRT Plus system is indicated for:
* Tracking respiratory motion throughout the simulation process to facilitate subsequent 4DCT reconstruction and coaching the patient in breathing techniques required for Deep- Inspiration Breath Hold (DIBH).
* Verification of patient identity for their radiation treatment session.
* Positioning and monitoring of patients during radiation delivery, relative to the setup isocenter and/or the prescribed treatment isocenter.
* Withholding the beam automatically during radiation delivery, as well as gating the beam based on the patient's respiratory motion.
* Performing quality assurance on MV, kV imagers, room lasers, and the treatment couch.
* Visualizing the Cherenkov signal associated with the radiation beam on entry and exit from the patient.
* Passing and receiving information to/from other systems associated with the radiotherapy treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253012: AlignRT Plus (8.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253012
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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