510(k) · Cleared
ClearedPlanmed Clarity 2D and Clarity S
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 Oct 23, 2020 as substantially equivalent to K163328 (Planmed OY, 2017) after a 424-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Oct 23, 2020
- Review
- 424 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P030010 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- 2 generations backK111361 Planmed Nuance ExcelPlanmeca USA, Inc. · 2011
- 1 generation backK163328 Planmed ClarityPlanmed OY · 2017
- This deviceK192317 Planmed Clarity 2D and Clarity SPlanmed OY · 2020
- Descendant · cites it directly · 0 of its ownK211720 Planmed Clarity 2D, Planmed Clarify SPlanmed OY · 2022
Most influential descendants
Showing 1 of 1 · See all- K211720Planmed Clarity 2D, Planmed Clarify SPlanmed OY · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| −2 | K111361 | Planmed Nuance Excel | Planmeca USA, Inc. | 2011 | — |
| −1 | K163328 | Planmed Clarity | Planmed OY | 2017 | — |
| 0 (this device) | K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | 2020 | — |
| +1 | K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K163328 | Planmed ClaritySummary page 4…atory Class: II Product Code: MUE III. PREDICATE DEVICE Planmed Clarity Full Field Digital Mammography X-ray System, K163328 This predicate system has not been subject to a design-related recall. No reference devices were used in this submi… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211720 | Planmed Clarity 2D, Planmed Clarify S | 2022 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K211720 (Planmed OY, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K163328.
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. 2020, 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 and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192317: Planmed Clarity 2D and Clarity S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192317
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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