510(k) · Cleared
ClearedAccusoft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direx Systems Corp. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jun 23, 2004 as substantially equivalent to K032171 (Direx Systems Corp., 2003) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Jun 23, 2004
- Review
- 120 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993895 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK993895 OptiradPermedics, Inc. · 2000
- 1 generation backK032171 AccusoftDirex Systems Corp. · 2003
- This deviceK040474 AccusoftDirex Systems Corp. · 2004
- Descendant · cites it directly · 1 of its ownK062032 Accusoft, Accusoft XLDirex Systems Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK063482 Crossplan / Accusoft-XL V.4.04Direx Systems Corp. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993895 | Optirad | Permedics, Inc. | 2000 | — |
| −1 | K032171 | Accusoft | Direx Systems Corp. | 2003 | — |
| 0 (this device) | K040474 | Accusoft | Direx Systems Corp. | 2004 | — |
| +1 | K062032 | Accusoft, Accusoft XL | Direx Systems Corp. | 2006 | — |
| +2 | K063482 | Crossplan / Accusoft-XL V.4.04 | Direx Systems Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.7 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032171 | AccusoftSummary page 2…cleared on * AccuSoft, v2.02., radiation treatment planning system December 15, 2003 (Tracking number K032171), manufacturer Direx Systems Corp. * DMLC IV - ERGO cleared on October 23, 2000 (Tracking number KOO 1163). M… | 2003 |
| * | K001163 | DMLC IV-Ergo | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062032 | Accusoft, Accusoft XL | 2006 | 1 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K062032 (Direx Systems Corp., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
Accusoft is to be used for the computation, display, evaluation, and output documentation of radiation dose estimations including those for Intensity Modulated Radiation Treatment (IMRT), 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/K040474 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040474: Accusoft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040474
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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