510(k) · Cleared
ClearedMRCAT Pelvis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems MR Finland · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Apr 30, 2019 as substantially equivalent to K151435 (Philips Medical Systems MR Finland, 2016) after a 197-day review. Its family tree reaches back 10 generations to 2001. 3 later devices descend from it.
- Decided
- Apr 30, 2019
- Review
- 197 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010975 (2001). 32 ancestors in all, the oldest K862643 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 2 generations backK130992 PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2013 · Recalled
- 1 generation backK151435 MRCATPhilips Medical Systems MR Finland · 2016
- This deviceK182888 MRCAT PelvisPhilips Medical Systems MR Finland · 2019
- Descendant · cites it directly · 2 of its ownK193109 MRCAT brainPhilips Medical Systems MR Finland · 2020
- Descendant · 2 generations on · 0 of its ownK211841 MRI PlannerSpectronic Medical AB · 2022
- Descendant · 2 generations on · 0 of its ownK214081 MRCAT Head & NeckPhilips OY · 2022
Show all 10 generations
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 9 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 8 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 7 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 6 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK102216 Xio RTP SystemComputerized Medical Systems, Inc. · 2010 · Recalled
- 2 generations backK130992 PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 2013 · Recalled
- 1 generation backK151435 MRCATPhilips Medical Systems MR Finland · 2016
- This deviceK182888 MRCAT PelvisPhilips Medical Systems MR Finland · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −9 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −8 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −7 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −6 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −5 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −4 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −3 | K102216 | Xio RTP System | Computerized Medical Systems, Inc. | 2010 | 7 |
| −2 | K130992 | PINNACLE3 Radiation Therapy Planning System | Philips Medical Systems (Cleveland), Inc. | 2013 | 1 |
| −1 | K151435 | MRCAT | Philips Medical Systems MR Finland | 2016 | — |
| 0 (this device) | K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | 2019 | — |
| +1 | K193109 | MRCAT brain | Philips Medical Systems MR Finland | 2020 | — |
| +2 | K211841 | MRI Planner | Spectronic Medical AB | 2022 | — |
| +2 | K214081 | MRCAT Head & Neck | Philips OY | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193109 | MRCAT brain | 2020 | 2 |
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 18 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 10 of the 32 ancestors have a recall of any class.
- Of its descendants, K193109 (Philips Medical Systems MR Finland, 2020) has gone furthest, with 2 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. 2019, 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?
MRCAT Pelvis is a software add-on for Ingenia 1.5T and 3.0T MR systems.
Intended Use:
MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.
Indications for use:
MRCAT Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182888: MRCAT Pelvis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182888
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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