510(k) · Cleared
ClearedHestia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoray Co., Ltd. · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Jul 17, 2025 as substantially equivalent to K212873 (Fujifilm Corporation, 2022) after a 255-day review. Its family tree reaches back 6 generations to 2004.
- Decided
- Jul 17, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to P030010 (2004). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backP030010 Siemens Mammomat Novationdr Full Field Digital Mammography SystemSiemens Medical Solution · 2004 · Recalled
- 5 generations backK110729 Aspire HD Full-Field Digital Mammography SystemFujifilm Medical Systems U.S.A, Inc. · 2011 · Recalled
- 4 generations backK121674 Aspire HD Plus, Aspire HD-SFujifilm Medical System U.S.A., Inc. · 2012 · Recalled
- 3 generations backK133972 Aspire CristalleFujifilm Medical Systems U.S.A, Inc. · 2014 · Recalled
- 2 generations backK173132 ASPIRE CristalleFujifilm Medical Systems U.S.A, Inc. · 2017
- 1 generation backK212873 Aspire CristalleFujifilm Corporation · 2022
- This deviceK243420 HestiaGenoray Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P030010 | Siemens Mammomat Novationdr Full Field Digital Mammography System | Siemens Medical Solution | 2004 | 2 |
| −5 | K110729 | Aspire HD Full-Field Digital Mammography System | Fujifilm Medical Systems U.S.A, Inc. | 2011 | 3 |
| −4 | K121674 | Aspire HD Plus, Aspire HD-S | Fujifilm Medical System U.S.A., Inc. | 2012 | 2 |
| −3 | K133972 | Aspire Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2014 | 2 |
| −2 | K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| −1 | K212873 | Aspire Cristalle | Fujifilm Corporation | 2022 | — |
| 0 (this device) | K243420 | Hestia | Genoray Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K212873 | Aspire CristalleSummary page 5…892.1715 Product Code(s) MUE I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K212873 Aspire Cristalle MUE Device Description Summary 21 CFR 807.92(a)(4) HESTIA is a Full-Field Digital Mammography (FFDM) System for… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 7 ancestors have a recall of any class.
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. 2025, 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?
HESTIA is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer.
HESTIA is intended to be used in the same clinical applications as traditional film/screen systems.
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/K243420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243420: Hestia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243420
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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