510(k) · Cleared
ClearedSonographic Planning of Oncology Treatments (Spot), Model V.. 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corp. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Mar 27, 2000 as substantially equivalent to K911612 (Nucletron-Oldelft Corp., 1991) and 1 other predicate after a 263-day review. Its family tree reaches back 1 generation to 1991. 6 later devices descend from it.
- Decided
- Mar 27, 2000
- Review
- 263 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K911612 (1991). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK911612 Nucletron Planning SystemNucletron-Oldelft Corp. · 1991
- This deviceK992303 Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0Nucletron Corp. · 2000
- Descendant · cites it directly · 4 of its ownK022739 Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model…Nucletron Corporation · 2002
- Descendant · 2 generations on · 3 of its ownK031158 Swift 2.0, Model 132.001Nucletron Corp. · 2003
- Descendant · cites it directly · 2 of its ownK022741 Spot Pro (220V), Model 131.099Nucletron Corporation · 2002
- Descendant · 2 generations on · 1 of its ownK112420 Oncentra Prostate 4.0Nucletron · 2011
- Descendant · 3 generations on · 0 of its ownK170841 BiopSee, Mobile USMedcom GmbH · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K022739Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002Nucletron Corporation · 2002 · cites it directly4descendants
- K031158Swift 2.0, Model 132.001Nucletron Corp. · 2003 · 2 generations on3descendants
- K022741Spot Pro (220V), Model 131.099Nucletron Corporation · 2002 · cites it directly2descendants
- K112420Oncentra Prostate 4.0Nucletron · 2011 · 2 generations on1descendant
- K170841BiopSee, Mobile USMedcom GmbH · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | 1991 | — |
| 0 (this device) | K992303 | Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0 | Nucletron Corp. | 2000 | — |
| +1 | K022739 | Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002 | Nucletron Corporation | 2002 | — |
| +2 | K031158 | Swift 2.0, Model 132.001 | Nucletron Corp. | 2003 | — |
| +1 | K022741 | Spot Pro (220V), Model 131.099 | Nucletron Corporation | 2002 | — |
| +2 | K112420 | Oncentra Prostate 4.0 | Nucletron | 2011 | — |
| +3 | K170841 | BiopSee, Mobile US | Medcom GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K915562 | PLATO Brachytherapy Planning System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…bstantially equivalent to the legally marketed predicate devices cited in the table below. Manufacturer Device 510(k) # Nucletron BV PLATO Brachytherapy Planning System K915562 Nucletron BV Nucletron Planning System K811612 LIS, inc LIS 6000A K961403 Appendix 5, page 2 Premarket Naotifica… | |
| * | K911612 | Nucletron Planning System Our OCR of the scanned summary read K811612, FDA’s number for Tryptic Soy Agar (Micro Media Laboratories). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nucletron Planning System”. | 1991 |
| * | K961403 | Life Imaging Systems Lis 6000 aSummary page 1…the table below. Manufacturer Device 510(k) # Nucletron BV PLATO Brachytherapy Planning System K915562 Nucletron BV Nucletron Planning System K811612 LIS, inc LIS 6000A K961403 Appendix 5, page 2 Premarket Naotification Nucletron Sonographic Planning of Oncology Treatments (SPOT) Date: Ju… | 1996 |
What descends from it? (6)
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?
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?
Brachytherapy planning, utilizing 3D Ultrasound Imaging, Sonographic Planning of Oncology Treatments (SPOT) is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion. From this information the patient can be treated with radioactive sources.
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/K992303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992303: Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992303
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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