510(k) · Cleared
ClearedAspire Cristalle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on May 27, 2022 as substantially equivalent to K173132 (Fujifilm Medical Systems U.S.A, Inc., 2017) after a 260-day review. Its family tree reaches back 5 generations to 2004. 1 later device descends from it.
- Decided
- May 27, 2022
- Review
- 260 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to P030010 (2004). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- 4 generations backK110729 Aspire HD Full-Field Digital Mammography SystemFujifilm Medical Systems U.S.A, Inc. · 2011 · Recalled
- 3 generations backK121674 Aspire HD Plus, Aspire HD-SFujifilm Medical System U.S.A., Inc. · 2012 · Recalled
- 2 generations backK133972 Aspire CristalleFujifilm Medical Systems U.S.A, Inc. · 2014 · Recalled
- 1 generation backK173132 ASPIRE CristalleFujifilm Medical Systems U.S.A, Inc. · 2017
- This deviceK212873 Aspire CristalleFujifilm Corporation · 2022
- Descendant · cites it directly · 0 of its ownK243420 HestiaGenoray Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243420HestiaGenoray Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| −4 | K110729 | Aspire HD Full-Field Digital Mammography System | Fujifilm Medical Systems U.S.A, Inc. | 2011 | 3 |
| −3 | K121674 | Aspire HD Plus, Aspire HD-S | Fujifilm Medical System U.S.A., Inc. | 2012 | 2 |
| −2 | K133972 | Aspire Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2014 | 2 |
| −1 | K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| 0 (this device) | K212873 | Aspire Cristalle | Fujifilm Corporation | 2022 | — |
| +1 | K243420 | Hestia | Genoray Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K173132 | ASPIRE CristalleSummary page 4…21 CFR 892.1715 Device Class: Class II Product Code: MUE Predicate Device: FUJIFILM ASPIRE Cristalle (FDR MS-3500) (K173132) Reference Device: GE SenoBright HD (K172404) Intended Use: The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR… | 2017 |
| † | K172404 | SenoBright HD | 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 |
|---|---|---|---|
| K243420 | Hestia | 2025 | 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 18 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K243420 (Genoray Co., Ltd., 2025) has gone furthest, with 0 descendants 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. 2022, 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 Fujifilm Digital Mammography System, ASPIRE Ceristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. Dual energy procedures is an optional feature of the ASPIRE Cristalle that can capture images consecutively under two…
Read the full statement (112 words)
The Fujifilm Digital Mammography System, ASPIRE Ceristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
Dual energy procedures is an optional feature of the ASPIRE Cristalle that can capture images consecutively under two different tube voltage conditions during one compression, and then create and display a subtraction image of the two acquired images. This optional feature shall enable contrast enhanced breast imaging and is used as an adjunct following mammography. Dual energy procedures is not intended for primary screening or diagnosis.
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/K212873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212873: Aspire Cristalle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212873
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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