510(k) · Cleared
Recalled · Class II · 2018Alignrt Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision RT Limited · IYE Accelerator, Linear, Medical
Cleared on Jan 8, 2013 as substantially equivalent to K052682 (Vision RT Limited, 2006) and 1 other predicate after a 68-day review. Its family tree reaches back 4 generations to 1987. 8 later devices descend from it. It has been recalled 5 times.
- Decided
- Jan 8, 2013
- Review
- 68 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K864886 (1987). 7 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
- 3 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
- 2 generations backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
- 1 generation backK072171 Gatect-RTVision RT Limited · 2007
- This deviceK123371 Alignrt PlusVision RT Limited · 2013
- Descendant · cites it directly · 7 of its ownK181218 AlignRT PlusVision Rt, Ltd. · 2018
- Descendant · 2 generations on · 6 of its ownK193431 AlignRT PlusVision Rt, Ltd. · 2020
- Descendant · 3 generations on · 5 of its ownK203387 AlignRT PlusVision Rt, Ltd. · 2021
- Descendant · 4 generations on · 4 of its ownK212583 AlignRT PlusVision Rt, Ltd. · 2021
- Descendant · 5 generations on · 2 of its ownK233622 AlignRT PlusVision Rt, Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181218AlignRT PlusVision Rt, Ltd. · 2018 · cites it directly7descendants
- K193431AlignRT PlusVision Rt, Ltd. · 2020 · 2 generations on6descendants
- K203387AlignRT PlusVision Rt, Ltd. · 2021 · 3 generations on5descendants
- K212583AlignRT PlusVision Rt, Ltd. · 2021 · 4 generations on4descendants
- K233622AlignRT PlusVision Rt, Ltd. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864886 | Respigraph-Respisomnograph-Respicentral | Nims/Respitrace Corp. | 1987 | — |
| −3 | K983629 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 1999 | — |
| −2 | K063270 | RPM Respiratory Gating System | Varian Medical Systems, Inc. | 2006 | 1 |
| −1 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| 0 (this device) | K123371 | Alignrt Plus | Vision RT Limited | 2013 | — |
| +1 | K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018 | — |
| +2 | K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020 | — |
| +3 | K203387 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| +4 | K212583 | AlignRT Plus | Vision Rt, Ltd. | 2021 | — |
| +5 | K233622 | AlignRT Plus | Vision Rt, Ltd. | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K052682 | AlignrtSummary page 1…* accessories, 9OIYE, (per 21 CFR section 892.5050) Predicate Device to claim substantial equivalence *Vision RT Align RT (K052682) Vision RT GateCT-RT (K072171) Description of Device: AlignIRT Plus system is a combination of the pre… | 2006 |
| * | K072171 | Gatect-RTSummary page 1…section 892.5050) Predicate Device to claim substantial equivalence *Vision RT Align RT (K052682) Vision RT GateCT-RT (K072171) Description of Device: AlignIRT Plus system is a combination of the predicate d6vices AlignRT (K052682) and GateCT-RT (K072171… | 2007 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181218 | AlignRT Plus | 2018 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2018 | Class II | Z-0065-2019 | Software design | RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB |
| Jun 30, 2016 | Class II | Z-2667-2016 | Other | Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical… |
| Jun 23, 2016 | Class II | Z-2149-2016 | Software design | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from… |
| Jun 23, 2016 | Class II | Z-2150-2016 | Software design | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from… |
| Oct 15, 2014 | Class II | Z-0464-2015 | Software in the Use Environment | Potential failure of AlignRT to assert interlock. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K181218 (Vision Rt, Ltd., 2018) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K052682.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 bead adjuster is included which can be used in concert wit AlignkT 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 (150 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 bead adjuster is included which can be used in concert wit AlignkT 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 as stated in the FDA summary.
https://510kreport.com/device/K123371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123371: Alignrt Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123371
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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