510(k) · Cleared
ClearedSentinel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C-Rad Positioning AB · IYE Accelerator, Linear, Medical
Cleared on Apr 20, 2020 as substantially equivalent to K120668 (C-Rad Positioning AB, 2012) after a 42-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Apr 20, 2020
- Review
- 42 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981153 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK981153 OsirisHuestis Medical · 1999
- 3 generations backK052682 AlignrtVision RT Limited · 2006 · Recalled
- 2 generations backK082582 Sentinel, Model SP-001C-Rad Positioning AB · 2009
- 1 generation backK120668 SentinelC-Rad Positioning AB · 2012
- This deviceK200600 SentinelC-Rad Positioning AB · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981153 | Osiris | Huestis Medical | 1999 | — |
| −3 | K052682 | Alignrt | Vision RT Limited | 2006 | 1 |
| −2 | K082582 | Sentinel, Model SP-001 | C-Rad Positioning AB | 2009 | — |
| −1 | K120668 | Sentinel | C-Rad Positioning AB | 2012 | — |
| 0 (this device) | K200600 | Sentinel | C-Rad Positioning AB | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K120668 | SentinelSummary page 4…ng system Classification name: Medical charged-particle radiation therapy system Regulation: 21 CFR 892.5050 Product code: IYE Predicate marketed device(s): Sentinel (K120668) Device description: The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the cei… | 2012 |
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 21 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
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 system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides:
• accurate and reproducible patient positioning.
• a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction.
The system cannot directly determine the location of the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200600: Sentinel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200600
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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