510(k) · Cleared
Recalled · Class II · 2017Aspire Cristalle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical Systems U.S.A, Inc. · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Mar 25, 2014 as substantially equivalent to K121674 (Fujifilm Medical System U.S.A., Inc., 2012) after an 89-day review. Its family tree reaches back 3 generations to 2004. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 25, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to P030010 (2004). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- 2 generations backK110729 Aspire HD Full-Field Digital Mammography SystemFujifilm Medical Systems U.S.A, Inc. · 2011 · Recalled
- 1 generation backK121674 Aspire HD Plus, Aspire HD-SFujifilm Medical System U.S.A., Inc. · 2012 · Recalled
- This deviceK133972 Aspire CristalleFujifilm Medical Systems U.S.A, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK173132 ASPIRE CristalleFujifilm Medical Systems U.S.A, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK212873 Aspire CristalleFujifilm Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK243420 HestiaGenoray Co., Ltd. · 2025
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 |
|---|---|---|---|---|---|
| −3 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| −2 | K110729 | Aspire HD Full-Field Digital Mammography System | Fujifilm Medical Systems U.S.A, Inc. | 2011 | 3 |
| −1 | K121674 | Aspire HD Plus, Aspire HD-S | Fujifilm Medical System U.S.A., Inc. | 2012 | 2 |
| 0 (this device) | K133972 | Aspire Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| +1 | K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| +2 | K212873 | Aspire Cristalle | Fujifilm Corporation | 2022 | — |
| +3 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K121674 | Aspire HD Plus, Aspire HD-SSummary page 1…Device Class: Class 11 Product Code: MUE Substantial Equivalence/Predicate Device: FUJIFILM Aspire HD Plus (FOR MS-2500) (K 121674) The predicate and proposed devices have the same Indication For Use (lEG). Roth devices generate digital mammographi… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173132 | ASPIRE Cristalle | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 4, 2017 | Class II | Z-0661-2018 | Software design | FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but… |
| Jul 14, 2017 | Class II | Z-0386-2018 | Employee error | There was a case that the swivel arm went down unintentionally when it was moved up/down. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K173132 (Fujifilm Medical Systems U.S.A, Inc., 2017) has gone furthest, with 2 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. 2014, 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 Cristalle (EDR 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133972 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133972: Aspire Cristalle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133972
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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