510(k) · Cleared
ClearedSoftdiso
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Nomos · IYE Accelerator, Linear, Medical
Cleared on Oct 27, 2017 as substantially equivalent to K101503 (Math Resolutions, LLC, 2010) after a 266-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Oct 27, 2017
- Review
- 266 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 6…DICATE DEVICE INFORMATION The predicate devices identified within this submission are as follows: a. Math Resolution, LL, Dosimetry Check with Exit Dose (510(K) No. K101503 (Decision Date: 04-August-2010)). K. COMPARISON TO THE PREDICATE DEVICE This section provides the summary of comparison… | 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 16 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. 2017, 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 SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems (LINAC Systems using high energy x-rays) to the patient. This solution is to be used as a quality control check purposes only. SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results…
Read the full statement (126 words)
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems (LINAC Systems using high energy x-rays) to the patient. This solution is to be used as a quality control check purposes only.
SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician’s responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170345: Softdiso.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170345
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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