510(k) · Cleared
ClearedXpert 40 Specimen 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 Jun 20, 2007 as substantially equivalent to K052433 (Bioptics, Inc., 2005) and 2 other predicates after a 48-day review. Its family tree reaches back 2 generations to 2002. 18 later devices descend from it.
- Decided
- Jun 20, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K021113 (2002). 4 ancestors in all, the oldest K953404 (1995). 18 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 1 generation backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- This deviceK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- Descendant · cites it directly · 15 of its ownK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- Descendant · 2 generations on · 14 of its ownK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
- Descendant · cites it directly · 3 of its ownK183624 Kubtec Mozart (Xpert42)Kub Technologies, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK182727 Trident HD Specimen Radiography SystemHologic, Inc. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K083510Kubtec Xpert 20Kub Technologies, Inc. · 2009 · cites it directly15descendants
- K111508Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011 · 2 generations on14descendants
- K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012 · 3 generations on4descendants
- K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc. · 2019 · cites it directly3descendants
- K182727Trident HD Specimen Radiography SystemHologic, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −1 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| 0 (this device) | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| +1 | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| +2 | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| +3 | K122428 | Faxitron Specien Radiography System | Faxitron Bioptics, LLC | 2012 | — |
| +1 | K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | 2019 | — |
| +3 | K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) SystemSummary page 2…Page 13 Predicate Device [21 CFR 807.92(a)(3)j o piXarray by Biotics - K052433 o Dx-50 by Faxitron-K061361 o MIX 20 by Faxitron - K953404 (the product formerly owned by Micro Focus Imaging) Description… | 2005 |
| * | K061361 | Faxitron Digital Radiography System, Model DX-50Summary page 2…Page 13 Predicate Device [21 CFR 807.92(a)(3)j o piXarray by Biotics - K052433 o Dx-50 by Faxitron-K061361 o MIX 20 by Faxitron - K953404 (the product formerly owned by Micro Focus Imaging) Description of the Device [21 CFR 807.92(a… | 2006 |
| * | K953404 | Osteo-Ray 100Summary page 2…Page 13 Predicate Device [21 CFR 807.92(a)(3)j o piXarray by Biotics - K052433 o Dx-50 by Faxitron-K061361 o MIX 20 by Faxitron - K953404 (the product formerly owned by Micro Focus Imaging) Description of the Device [21 CFR 807.92(a)(4)] The XPERT Specimen Ra… | 1995 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083510 (Kub Technologies, Inc., 2009) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K052433.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071233 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071233: Xpert 40 Specimen Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071233
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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