510(k) · Cleared
ClearedKubtec Mozart Supra (XPERT 84) Radiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kub Technologies, Inc. · MWP Cabinet, X-Ray System
Cleared on Sep 20, 2021 as substantially equivalent to K200756 (Kub Technologies, Inc., 2020) and 2 other predicates after a 174-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Sep 20, 2021
- Review
- 174 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K941191 (1995). 24 ancestors in all, the oldest K921962 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK941191 Real Time StereotixGE Medical Systems · 1995 · Recalled
- 6 generations backK040125 Senographic StereoGe Medical Systems, Inc. · 2004
- 5 generations backK071542 Digital Stereoloc IILorad, A Hologic Co. · 2007
- 4 generations backK103512 Affirm Breast Biopsy Guidance SystemHologic, Inc. · 2011
- 3 generations backK122836 Affirm Breast Biopsy Guidance SystemLorad, A Hologic Co. · 2013
- 2 generations backK173408 Mammomat RevelationSiemens Medi Cal Solutions, Inc. · 2018 · Recalled
- 1 generation backK193166 MAMMOMAT RevelationSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- This deviceK210955 Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941191 | Real Time Stereotix | GE Medical Systems | 1995 | 2 |
| −6 | K040125 | Senographic Stereo | Ge Medical Systems, Inc. | 2004 | — |
| −5 | K071542 | Digital Stereoloc II | Lorad, A Hologic Co. | 2007 | — |
| −4 | K103512 | Affirm Breast Biopsy Guidance System | Hologic, Inc. | 2011 | — |
| −3 | K122836 | Affirm Breast Biopsy Guidance System | Lorad, A Hologic Co. | 2013 | — |
| −2 | K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018 | 2 |
| −1 | K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| 0 (this device) | K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 MWP? 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 MWP device
- #1 K202713 TrueView 100 Proscore 7.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K200756 | Kubtec Mozart SupraSummary page 5…ed camera and Kubtec DIGICOM Specimen Radiography software. To support the Tomosynthesis application, the predicate device, MOZART SUPRA (XPERT84), K200756, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monobloc… | 2020 |
| * | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001Summary page 8…devices: PRIMARY: 510(k) Number: K200756 Trade Name: Kubtec MOZART SUPRA (XPERT84) Specimen Radiography System SECONDARY: 510(k) Number: K 111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY 510(k) Number: K 193166 Trade Name: Siemens MAMMOMAT Revelation… | 2011 |
| * | K193166 | MAMMOMAT RevelationSummary page 8…A (XPERT84) Specimen Radiography System SECONDARY: 510(k) Number: K 111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY 510(k) Number: K 193166 Trade Name: Siemens MAMMOMAT Revelation Predicate Device: Device Name: Kubtec MOZART SUPRA (XP… | 2020 |
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 26 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- 7 of the 24 ancestors have a recall of any class.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MWP
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MWP
154in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWP
No recall names MWP since 2007.
Adverse event reports per year · MWP
1in 2025
MAUDE reports naming product code MWP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 5 | 104 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 154 | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2-dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210955: Kubtec Mozart Supra (XPERT 84) Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210955
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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