510(k) · Cleared
ClearedKubec Xpert 80 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 Aug 31, 2021 as substantially equivalent to K071233 (Kub Technologies, Inc., 2007) and 2 other predicates after a 154-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Aug 31, 2021
- Review
- 154 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K941191 (1995). 22 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 deviceK210957 Kubec Xpert 80 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) | K210957 | Kubec Xpert 80 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 |
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 |
|---|---|---|---|
| * | K071233 | Xpert 40 Specimen Radiography SystemSummary page 5…VALENCE The proposed Kubtec XPERT 80 Specimen Radiography System is substantially equivalent to the following currently cleared devices: 1. 510(k) Number: K071233 Trade Name: Kubtec XPERT 40/80/80L Specimen Radiography System (primary predicate) 2. 510(k) Number:… | 2007 |
| * | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001Summary page 5…1. 510(k) Number: K071233 Trade Name: Kubtec XPERT 40/80/80L Specimen Radiography System (primary predicate) 2. 510(k) Number: K 111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY 3. 510(k) Number: K 193166 Trade Name: Siemens MAMM… | 2011 |
| * | K193166 | MAMMOMAT RevelationSummary page 5…graphy System (primary predicate) 2. 510(k) Number: K 111508 Trade Name: Hologic TRIDENT SPECIMEN RADIOGRAPHY 3. 510(k) Number: K 193166 Trade Name: Siemens MAMMOMAT Revelation The only difference between the predicate to the Kubtec XPERT 40/80/80L… | 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 22 ancestors have a recall of any class.
- 4 other devices also cite its predicate K071233.
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 Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
It is not used for mammography
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/K210957 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210957: Kubec Xpert 80 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/K210957
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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