510(k) · Cleared
ClearedEDOSE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Raydose Software Technology., LLC · IYE Accelerator, Linear, Medical
Cleared on Aug 17, 2015 as substantially equivalent to K101503 (Math Resolutions, LLC, 2010) after a 146-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Aug 17, 2015
- Review
- 146 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010225 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K101503 | Dusimetry CheckSummary page 4…The identified predicates within this submission are as follows: Math Resolutions, LLC, Dosimetry Check with Exit Dose has been cleared by FDA through 510(k) No.K101503 (Decision Date – August 04, 2010), 510(k) Summary 7-1… | 2010 |
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 14 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K101503.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are planned to be applied or have been applied to a patient. By using the specific measuring device…
Read the full statement (139 words)
EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are planned to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150767: EDOSE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150767
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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