510(k) · Cleared
ClearedOptirad
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 Jun 2, 2000 after a 199-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jun 2, 2000
- Review
- 199 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK993895 OptiradPermedics, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK032171 AccusoftDirex Systems Corp. · 2003
- Descendant · cites it directly · 2 of its ownK042861 OdysseyPermedics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 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 5 of 5 · See all- K032171AccusoftDirex Systems Corp. · 2003 · cites it directly3descendants
- K042861OdysseyPermedics, Inc. · 2005 · cites it directly2descendants
- K040474AccusoftDirex Systems Corp. · 2004 · 2 generations on2descendants
- K062032Accusoft, Accusoft XLDirex Systems Corp. · 2006 · 2 generations on1descendant
- K063482Crossplan / Accusoft-XL V.4.04Direx Systems Corp. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993895 | Optirad | Permedics, Inc. | 2000 | — |
| +1 | K032171 | Accusoft | Direx Systems Corp. | 2003 | — |
| +1 | K042861 | Odyssey | Permedics, Inc. | 2005 | 2 |
| +2 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 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? (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 |
|---|---|---|---|
| * | — | Rocs TPS Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K032171 (Direx Systems Corp., 2003) has gone furthest, with 3 descendants 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?
The OptiRad software is to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgement prior to use. The device provides output data in the form of displays and/or hardcopies 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993895: Optirad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993895
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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