510(k) · Cleared
ClearedFaxitron Specien Radiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Faxitron Bioptics, LLC · MWP Cabinet, X-Ray System
Cleared on Sep 25, 2012 as substantially equivalent to K111508 (Hologic, Inc., 2011) and 2 other predicates after a 47-day review. Its family tree reaches back 5 generations to 2002. 4 later devices descend from it.
- Decided
- Sep 25, 2012
- Review
- 47 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K021113 (2002). 10 ancestors in all, the oldest K852634 (1985). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 4 generations backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- 3 generations backK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- 2 generations backK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- 1 generation backK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- This deviceK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
- Descendant · cites it directly · 2 of its ownK170786 Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK173309 Faxitron VisionCTFaxitron Bioptics, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK192939 Volumetric Specimen ImagerClarix Imaging · 2019
- Descendant · cites it directly · 0 of its ownK183142 PathVisionXLFaxitron Bioptics, LLC · 2019
Most influential descendants
Showing 4 of 4 · See all- K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017 · cites it directly2descendants
- K173309Faxitron VisionCTFaxitron Bioptics, LLC · 2018 · 2 generations on1descendant
- K192939Volumetric Specimen ImagerClarix Imaging · 2019 · 3 generations on0descendants
- K183142PathVisionXLFaxitron Bioptics, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −4 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| −3 | 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 | — |
| 0 (this device) | K122428 | Faxitron Specien Radiography System | Faxitron Bioptics, LLC | 2012 | — |
| +1 | K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017 | — |
| +2 | K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018 | — |
| +3 | K192939 | Volumetric Specimen Imager | Clarix Imaging | 2019 | — |
| +1 | K183142 | PathVisionXL | Faxitron Bioptics, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001Summary page 1…igital Specimen Radiography System is substantially equivalent to the following to the following predicate devices: A. Hologic Trident Specimen Radiography System (K1 11508) 6. Faxitron Specimen Radiography System Model MX20 (K072557), C. Bioptics BioVisionDigital Specimen Radiography Syst… | 2011 |
| * | K072557 | Faxitron Specimen Radiography System, Model MX-20Summary page 1…e following to the following predicate devices: A. Hologic Trident Specimen Radiography System (K1 11508) 6. Faxitron Specimen Radiography System Model MX20 (K072557), C. Bioptics BioVisionDigital Specimen Radiography System (K091558) Faxitron Bioptics LLC' PathVision 510(k) Submissio… | 2007 |
| * | K091558 | Biovision Digital Specimen Radiography SystemSummary page 1…pecimen Radiography System (K1 11508) 6. Faxitron Specimen Radiography System Model MX20 (K072557), C. Bioptics BioVisionDigital Specimen Radiography System (K091558) Faxitron Bioptics LLC' PathVision 510(k) Submission Page 7 of 31 DEVICE DESCRIPTION - as requir… | 2009 |
What descends from it? (4)
2 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 10 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K170786 (Faxitron Bioptics, LLC, 2017) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K111508.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 PathVision is a Cabinet x-ray system that is used to provide film and/or 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 as stated in the FDA summary.
https://510kreport.com/device/K122428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122428: Faxitron Specien Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122428
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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