510(k) · Cleared
ClearedAccusoft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direx Systems Corp. · IYE Accelerator, Linear, Medical
Cleared on Dec 15, 2003 as substantially equivalent to K993895 (Permedics, Inc., 2000) after a 152-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Dec 15, 2003
- Review
- 152 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993895 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK993895 OptiradPermedics, Inc. · 2000
- This deviceK032171 AccusoftDirex Systems Corp. · 2003
- Descendant · cites it directly · 2 of its ownK040474 AccusoftDirex Systems Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK062032 Accusoft, Accusoft XLDirex Systems Corp. · 2006
- Descendant · 3 generations on · 0 of its ownK063482 Crossplan / Accusoft-XL V.4.04Direx Systems Corp. · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993895 | Optirad | Permedics, Inc. | 2000 | — |
| 0 (this device) | K032171 | Accusoft | Direx Systems Corp. | 2003 | — |
| +1 | K040474 | Accusoft | Direx Systems Corp. | 2004 | — |
| +2 | K062032 | Accusoft, Accusoft XL | Direx Systems Corp. | 2006 | — |
| +3 | K063482 | Crossplan / Accusoft-XL V.4.04 | Direx Systems Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K993895 | OptiradSummary page 1…ified this type of devices as class II (product code 90 lYE, Regulation No. 892.5050) and they are reviewed by the Radiology Panel. Predicate Devices: PerMedics' OptiRad k993895 Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Food, Drug… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040474 | Accusoft | 2004 | 2 |
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?
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?
AccuSoft is to be used for the computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment by a physicist or physician prior to use. The device provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032171 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032171: Accusoft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032171
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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