510(k) · Cleared
Recalled · 2010Odyssey
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permedics, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 12, 2005 as substantially equivalent to K002237 (Adac Laboratories, 2001) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 12, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K993895 (2000). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK993895 OptiradPermedics, Inc. · 2000
- This deviceK042861 OdysseyPermedics, Inc. · 2005
- 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 |
|---|---|---|---|---|---|
| −1 | K993895 | Optirad | Permedics, Inc. | 2000 | — |
| 0 (this device) | K042861 | Odyssey | Permedics, Inc. | 2005 | — |
| +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 |
|---|---|---|
| 2001 | 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 18.6 · 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 |
|---|---|---|---|
| * | K002237 | P3IMRT TMSummary page 1…4 Device Name: Odyssey Common Name: Radiation Treatment Planning System Classification Name: System, Planning, Radiation Treatment Predicate Devices: ADAC P'IMRTTM - K002237 OptiRad - K993895 Device Description: The Odyssey radiation treatment planning system is a collection of software modules that e… | 2001 |
| * | K993895 | OptiradSummary page 1…yssey Common Name: Radiation Treatment Planning System Classification Name: System, Planning, Radiation Treatment Predicate Devices: ADAC P'IMRTTM - K002237 OptiRad - K993895 Device Description: The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2010 | Not classified | Z-0345-2012 | Device Design | Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files: During PerMedics' internal code reviews for lEC 61217 compliance verification, an issue was identified by PerMedics… |
| Mar 23, 2010 | Not classified | Z-1609-2010 | Other | Anomaly 1, Invalid Characters in Patient ID Error: Currently, Odyssey considers a valid ID to be comprised of numbers and/or letters. If a patient ID in a study contains a character other than a letter or number (including spaces).… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Odyssey is to be used for the computation, display, evaluation and output of radiation
dose estimations to be submitted for independent clinical review and judgment prior to
use in radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042861: Odyssey.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042861
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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