510(k) · Cleared
ClearedFaxitron Digital Radiography System, Model DX-50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Faxitron X-Ray Corp. · MWP Cabinet, X-Ray System
Cleared on Aug 15, 2006 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 20 later devices descend from it.
- Decided
- Aug 15, 2006
- Review
- 91 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly.
- This deviceK061361 Faxitron Digital Radiography System, Model DX-50Faxitron X-Ray Corp. · 2006
- Descendant · cites it directly · 18 of its ownK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- Descendant · 2 generations on · 15 of its ownK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK072557 Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp. · 2007
- Descendant · 2 generations on · 4 of its ownK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K071233Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007 · cites it directly18descendants
- K083510Kubtec Xpert 20Kub Technologies, Inc. · 2009 · 2 generations on15descendants
- K111508Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011 · cites it directly14descendants
- K072557Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp. · 2007 · cites it directly5descendants
- K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061361 | Faxitron Digital Radiography System, Model DX-50 | Faxitron X-Ray Corp. | 2006 | — |
| +1 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| +2 | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| +1 | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| +1 | K072557 | Faxitron Specimen Radiography System, Model MX-20 | Faxitron X-Ray Corp. | 2007 | — |
| +2 | K122428 | Faxitron Specien Radiography System | Faxitron Bioptics, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (20)
See all 203 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?
- Of its descendants, K071233 (Kub Technologies, Inc., 2007) has gone furthest, with 18 descendants of its own.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DX-50 is a Cabinet x-ray system that is used to provide digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061361: Faxitron Digital Radiography System, Model DX-50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061361
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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