510(k) · Cleared
ClearedKonica Minolta Xpress Digital Mammography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Medical & Graphic, Inc. · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on Dec 23, 2011 as substantially equivalent to P050014 (Fujifilm Medical System U.S.A., Inc., 2006) after a 283-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Dec 23, 2011
- Review
- 283 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P050014 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backP050014 Fuji's Computed Radiography Mammography Suite (Fcrms)Fujifilm Medical System U.S.A., Inc. · 2006 · Recalled
- This deviceK110717 Konica Minolta Xpress Digital Mammography SystemKonica Minolta Medical & Graphic, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P050014 | Fuji's Computed Radiography Mammography Suite (Fcrms) | Fujifilm Medical System U.S.A., Inc. | 2006 | 1 |
| 0 (this device) | K110717 | Konica Minolta Xpress Digital Mammography System | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | P050014 | Fuji's Computed Radiography Mammography Suite (Fcrms)Summary page 1…tion Name:Full Field Digital Maiimography System Common Name: Xpress Digital Mammography System Proprietary Name: Xpress Digital Mamniogiaphy System Predicate Devices: P050014 o Fuji Computed Radiography Mammography Suite (FCRMS). Device Description: Konjca Minoita’s Xpress Digital Mammography is a sof… | 2006 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate P050014.
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. 2011, 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 Konica Minolta Xpress Digital Mammography System is a software device that is used in conjunction with a specified Konica Minolta computed radiography system, REGIUS Model 190 or REGIUS Model 210 with REGIUS Cassette Plate CP1M200 and the REGIUS Console CS-3000, and a mammography x-ray unit, to produce full field digital mammography images. The Xpress Digital Mammography software with a specified Konica Minolta computed radiography system is designed…
Read the full statement (115 words)
The Konica Minolta Xpress Digital Mammography System is a software device that is
used in conjunction with a specified Konica Minolta computed radiography system,
REGIUS Model 190 or REGIUS Model 210 with REGIUS Cassette Plate CP1M200 and
the REGIUS Console CS-3000, and a mammography x-ray unit, to produce full field
digital mammography images. The Xpress Digital Mammography software with a
specified Konica Minolta computed radiography system is designed to replace screen-film
based systems for the production of mammographic images. The device is intended to be
used for screening and diagnosis of breast cancer. The mammographic images can be
interpreted by a qualified physician using either hard copy film or soft copy display at a
workstation.
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/K110717 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110717: Konica Minolta Xpress Digital Mammography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110717
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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