510(k) · Cleared
ClearedPrelude
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcom GmbH · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Mar 27, 2018 as substantially equivalent to K171885 (Gmv Soluciones Globales Internet S.A.U., 2017) after a 53-day review. Its family tree reaches back 13 generations to 1986.
- Decided
- Mar 27, 2018
- Review
- 53 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K864210 (1986). 64 ancestors in all, the oldest K852907 (1985). No later device cites it as a predicate yet.
- Root · 13 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 9 generations between
- 3 generations backK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- 2 generations backK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- 1 generation backK171885 Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
- This deviceK180308 PreludeMedcom GmbH · 2018
Show all 13 generations
- Root · 13 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 12 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 11 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
- 10 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
- 9 generations backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
- 8 generations backK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
- 7 generations backK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
- 6 generations backK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
- 5 generations backK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- 4 generations backK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
- 3 generations backK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014
- 2 generations backK153368 Radiance V3Gmv Soluciones Globales Internet S.A.U. · 2016
- 1 generation backK171885 Radiance V4Gmv Soluciones Globales Internet S.A.U. · 2017
- This deviceK180308 PreludeMedcom GmbH · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −12 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −11 | K983337 | Rotterdam Nasophayrnx Mould Set, Part #089.068 | Nucletron Corp. | 1999 | — |
| −10 | K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2002 | — |
| −9 | K030558 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2003 | — |
| −8 | K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader… | Proxima Therapeutics, Inc. | 2004 | — |
| −7 | K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | 2007 | — |
| −6 | K081079 | Contura MLB Source Applicator for Brachytherapy | Senorx, Inc. | 2008 | — |
| −5 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| −4 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
| −3 | K133655 | Radiance V2 | Gmv Soluciones Globales Internet S.A.U. | 2014 | — |
| −2 | K153368 | Radiance V3 | Gmv Soluciones Globales Internet S.A.U. | 2016 | — |
| −1 | K171885 | Radiance V4 | Gmv Soluciones Globales Internet S.A.U. | 2017 | — |
| 0 (this device) | K180308 | Prelude | Medcom GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K171885 | Radiance V4Summary page 5…of 41 C. Predicate Devices Device trade name: Radiance 510(k) number: K171885 Company name: GMV Classification Number: 892.5… | 2017 |
| * | — | Track-it Named without a submission number |
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 32 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 15 of the 64 ancestors have a recall of any class.
- 2 other devices also cite its predicate K171885.
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. 2018, 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?
The Prelude Planning Software for the electron beam IORT treatment can be used for any malignant and benign tumor.
For Prelude no limitation is given to the patient population. Local/Regional recommendations or guidelines may indicate patient who will benefit from IORT more than from other treatment modalities.
In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180308: Prelude.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180308
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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