510(k) · Cleared
ClearedMRI Planner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectronic Medical AB · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Aug 25, 2022 as substantially equivalent to K193109 (Philips Medical Systems MR Finland, 2020) after a 437-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Aug 25, 2022
- Review
- 437 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K010975 (2001). 34 ancestors in all, the oldest K862643 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 8 generations between
- 3 generations backK151435 MRCATPhilips Medical Systems MR Finland · 2016
- 2 generations backK182888 MRCAT PelvisPhilips Medical Systems MR Finland · 2019
- 1 generation backK193109 MRCAT brainPhilips Medical Systems MR Finland · 2020
- This deviceK211841 MRI PlannerSpectronic Medical AB · 2022
Show all 12 generations
- Root · 12 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 11 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 10 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 9 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 8 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 7 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 6 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 5 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 4 generations backK130992 PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2013 · Recalled
- 3 generations backK151435 MRCATPhilips Medical Systems MR Finland · 2016
- 2 generations backK182888 MRCAT PelvisPhilips Medical Systems MR Finland · 2019
- 1 generation backK193109 MRCAT brainPhilips Medical Systems MR Finland · 2020
- This deviceK211841 MRI PlannerSpectronic Medical AB · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −11 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −10 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −9 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −8 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −7 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −6 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −5 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −4 | K130992 | PINNACLE3 Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | 2013 | 1 |
| −3 | K151435 | MRCAT | Philips Medical Systems MR Finland | 2016 | — |
| −2 | K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | 2019 | — |
| −1 | K193109 | MRCAT brain | Philips Medical Systems MR Finland | 2020 | — |
| 0 (this device) | K211841 | MRI Planner | Spectronic Medical AB | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 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.
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 10 of the 34 ancestors have a recall of any class.
- 1 other device also cites its predicate K193109.
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. 2022, this device’s year, is highlighted.
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?
MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process images from MRI systems to 1) provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning, and to 2) derive contours for input to radiation treatment planning by assisting in localization and definition of healthy…
Read the full statement (148 words)
MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process images from MRI systems to
1) provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning, and to
2) derive contours for input to radiation treatment planning by assisting in localization and definition of healthy anatomical structures.
MRI Planner is not intended to automatically contour tumors or tumor clinical target volumes.
MRI Planner is indicated for radiotherapy planning of adult patients for primary and metastatic cancers in the brain and head-neck regions, as well as soft tissue cancers in the pelvic region.
MRI Planner generates synthetic CT images for radiation attenuation estimation purposes for the pelvis, brain and head-neck regions only. MRI Planner generates automatically derived contours of the bladder, colon and femoral heads, for prostate cancer patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211841: MRI Planner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211841
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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