510(k) · Cleared
ClearedPrefernce Imrt Treatment Planning Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northwest Medical Physics Equipment, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Mar 12, 2002 as substantially equivalent to K970464 (Northwest Medical Physics Equipment, Inc., 1997) and 1 other predicate after a 215-day review. Its family tree reaches back 2 generations to 1997. 12 later devices descend from it.
- Decided
- Mar 12, 2002
- Review
- 215 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970464 (1997). 12 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK970464 P Reference TPS (Treatment Planning Software) 1.1Northwest Medical Physics Equipment, Inc. · 1997
- 1 generation backK983793 Preference Treatment SystemNorthwest Medical Physics Equipment, Inc. · 1999
- This deviceK012575 Prefernce Imrt Treatment Planning ModuleNorthwest Medical Physics Equipment, Inc. · 2002
- Descendant · cites it directly · 11 of its ownK060906 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK112768 Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK123137 Calypso SystemVarian Medical Systems · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2006 · cites it directly11descendants
- K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 2 generations on9descendants
- K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010 · 2 generations on6descendants
- K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2011 · 2 generations on4descendants
- K123137Calypso SystemVarian Medical Systems · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970464 | P Reference TPS (Treatment Planning Software) 1.1 | Northwest Medical Physics Equipment, Inc. | 1997 | — |
| −1 | K983793 | Preference Treatment System | Northwest Medical Physics Equipment, Inc. | 1999 | — |
| 0 (this device) | K012575 | Prefernce Imrt Treatment Planning Module | Northwest Medical Physics Equipment, Inc. | 2002 | — |
| +1 | K060906 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2006 | — |
| +2 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| +2 | K102373 | Calypso System with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2010 | — |
| +2 | K112768 | Calypso Systems with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2011 | — |
| +2 | K123137 | Calypso System | Varian Medical Systems | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K970464 | P Reference TPS (Treatment Planning Software) 1.1Summary page 3…duct) Device Name: pReference IMRT Treatment Planning Module . Indications For Use: The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcino… | 1997 |
| * | K983793 | Preference Treatment SystemSummary page 3…s, arteriovenous malformations, and metastatic carcinomas. The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors. The software is used to electronic… | 1999 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060906 | Calypso 4D Localization System | 2006 | 11 |
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 5 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060906 (Calypso Medical Technologies, Inc., 2006) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K970464.
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 indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas. The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors. The software is used…
Read the full statement (96 words)
The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012575: Prefernce Imrt Treatment Planning Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012575
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026