510(k) · Cleared
ClearedPlanmed Clarity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmed OY · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Dec 28, 2017 as substantially equivalent to K111361 (Planmeca USA, Inc., 2011) after a 395-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it.
- Decided
- Dec 28, 2017
- Review
- 395 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P030010 (2004). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- 1 generation backK111361 Planmed Nuance ExcelPlanmeca USA, Inc. · 2011
- This deviceK163328 Planmed ClarityPlanmed OY · 2017
- Descendant · cites it directly · 1 of its ownK192317 Planmed Clarity 2D and Clarity SPlanmed OY · 2020
- Descendant · 2 generations on · 0 of its ownK211720 Planmed Clarity 2D, Planmed Clarify SPlanmed OY · 2022
- Descendant · cites it directly · 0 of its ownK202822 HelianthusMetaltronica Spa · 2021
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 |
|---|---|---|---|---|---|
| −2 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| −1 | K111361 | Planmed Nuance Excel | Planmeca USA, Inc. | 2011 | — |
| 0 (this device) | K163328 | Planmed Clarity | Planmed OY | 2017 | — |
| +1 | K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | 2020 | — |
| +2 | K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | 2022 | — |
| +1 | K202822 | Helianthus | Metaltronica Spa | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111361 | Planmed Nuance ExcelSummary page 4…tory Class: II Product Code: MUE III. PREDICATE DEVICE Planmed Nuance Excel Full Field Digital Mammography System, K111361 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2011 |
What descends from it? (3)
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K192317 (Planmed OY, 2020) has gone furthest, with 1 descendant of its own.
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. 2017, 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?
The Planmed Clarity 2D mammography unit acquires digital 2D mammographic images. The Planmed Clarity 2D system is intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity system may also be used for additional diagnostic workup of the breast.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163328: Planmed Clarity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163328
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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