510(k) · Cleared
ClearedPlanmed Nuance Excel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmeca USA, Inc. · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Sep 23, 2011 as substantially equivalent to P030010 (Siemens Medical Solution, 2004) after a 130-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.
- Decided
- Sep 23, 2011
- Review
- 130 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P030010 (2004). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- This deviceK111361 Planmed Nuance ExcelPlanmeca USA, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK163328 Planmed ClarityPlanmed OY · 2017
- Descendant · 2 generations on · 1 of its ownK192317 Planmed Clarity 2D and Clarity SPlanmed OY · 2020
- Descendant · 3 generations on · 0 of its ownK211720 Planmed Clarity 2D, Planmed Clarify SPlanmed OY · 2022
- Descendant · 2 generations on · 0 of its ownK202822 HelianthusMetaltronica Spa · 2021
Most influential descendants
Showing 4 of 4 · See all- K163328Planmed ClarityPlanmed OY · 2017 · cites it directly3descendants
- K192317Planmed Clarity 2D and Clarity SPlanmed OY · 2020 · 2 generations on1descendant
- K211720Planmed Clarity 2D, Planmed Clarify SPlanmed OY · 2022 · 3 generations on0descendants
- K202822HelianthusMetaltronica Spa · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| 0 (this device) | K111361 | Planmed Nuance Excel | Planmeca USA, Inc. | 2011 | — |
| +1 | K163328 | Planmed Clarity | Planmed OY | 2017 | — |
| +2 | K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | 2020 | — |
| +3 | K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | 2022 | — |
| +2 | K202822 | Helianthus | Metaltronica Spa | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 MUE? 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 MUE device
- #1 K253678 MAMMOMAT B.brilliant (11372950)score 13.6 · 8 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography SystemSummary page 2…er this product modification to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976: PMA # 030010 Siemens Mammomat Novation DR The comparison of characteristics supports substantial equivalence. Planmed Nuance Excel is… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163328 | Planmed Clarity | 2017 | 3 |
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 MUE devicesMUE Full Field Digital, System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MUE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUE
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUE
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUE
40in 2025
MAUDE reports naming product code MUE, 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 | 6 | — | 0 | 0 |
| 2008 | 5 | — | 1 | 4 |
| 2009 | 8 | — | 1 | 3 |
| 2010 | 10 | — | 2 | 2 |
| 2011 | 10 | 192 | 5 | 10 |
| 2012 | 4 | 123 | 0 | 6 |
| 2013 | 7 | 207 | 0 | 11 |
| 2014 | 1 | — | 2 | 7 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 19 |
| 2017 | 8 | 95 | 6 | 115 |
| 2018 | 2 | — | 1 | 145 |
| 2019 | 2 | — | 1 | 80 |
| 2020 | 4 | 188 | 0 | 49 |
| 2021 | 4 | 164 | 0 | 25 |
| 2022 | 3 | 404 | 0 | 36 |
| 2023 | 1 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 3 | 255 | 4 | 40 |
| 2026 | 4 | 185 | 1 | — |
What is it indicated for?
Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units.
The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.
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/K111361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111361: Planmed Nuance Excel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111361
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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