510(k) · Cleared
ClearedOsiris
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huestis Medical · IYE Accelerator, Linear, Medical
Cleared on Mar 17, 1999 after a 352-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it.
- Decided
- Mar 17, 1999
- Review
- 352 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 1 citing it directly.
- This deviceK981153 OsirisHuestis Medical · 1999
- Descendant · cites it directly · 18 of its ownK052682 AlignrtVision RT Limited · 2006 · Recalled
- Descendant · 2 generations on · 12 of its ownK072171 Gatect-RTVision RT Limited · 2007
- Descendant · 2 generations on · 8 of its ownK123371 Alignrt PlusVision RT Limited · 2013 · Recalled
- Descendant · 3 generations on · 7 of its ownK181218 AlignRT PlusVision Rt, Ltd. · 2018
- Descendant · 4 generations on · 6 of its ownK193431 AlignRT PlusVision Rt, Ltd. · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K052682AlignrtVision RT Limited · 2006 · cites it directly18descendants
- K072171Gatect-RTVision RT Limited · 2007 · 2 generations on12descendants
- K123371Alignrt PlusVision RT Limited · 2013 · 2 generations on8descendants
- K181218AlignRT PlusVision Rt, Ltd. · 2018 · 3 generations on7descendants
- K193431AlignRT PlusVision Rt, Ltd. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981153 | Osiris | Huestis Medical | 1999 | — |
| +1 | K052682 | Alignrt | Vision RT Limited | 2006 | 1 |
| +2 | K072171 | Gatect-RT | Vision RT Limited | 2007 | — |
| +2 | K123371 | Alignrt Plus | Vision RT Limited | 2013 | 5 |
| +3 | K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018 | — |
| +4 | K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052682 | Alignrt | 2006 | 18 |
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?
- Of its descendants, K052682 (Vision RT Limited, 2006) has gone furthest, with 18 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 OSIRIS optical outline system is used to measure patient contours for the purpose of radiotherapy treatment planning. Its main applications are for breast and abdomen treatment planning. The system utilizes existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours. The professional groups using the OSIRIS system can include Medical staff, radiographers, technicians and medical physicists — all of…
Read the full statement (157 words)
The OSIRIS optical outline system is used to measure patient contours for the purpose of radiotherapy treatment planning. Its main applications are for breast and abdomen treatment planning. The system utilizes existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours.
The professional groups using the OSIRIS system can include Medical staff, radiographers, technicians and medical physicists — all of whom are professionally employed within a radiotherapy department and are specialists in the use of surface contours for radiotherapy treatments. The main users are those who use Radiotherapy Simulators for treatment simulation and verification, and the staff who treat patients on linear accelerator therapy machines. The same groups of staff will use the surface contours for isodose production, where appropriate, and define the setup data and any additional measurements required, according to the QA programs running in that department.
Typical application is in the measurement and calculation of missing tissue compensator filters.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981153 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981153: Osiris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981153
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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