510(k) · Cleared
ClearedFaxitron Specimen Radiography System, Model MX-20
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 Oct 30, 2007 as substantially equivalent to K852634 (Micro-Focus Imaging., Inc., 1985) and 2 other predicates after a 49-day review. Its family tree reaches back 2 generations to 2002. 5 later devices descend from it.
- Decided
- Oct 30, 2007
- Review
- 49 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 K852634 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 1 generation backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- This deviceK072557 Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp. · 2007
- Descendant · cites it directly · 4 of its ownK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK170786 Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017
- Descendant · 3 generations on · 1 of its ownK173309 Faxitron VisionCTFaxitron Bioptics, LLC · 2018
- Descendant · 4 generations on · 0 of its ownK192939 Volumetric Specimen ImagerClarix Imaging · 2019
- Descendant · 2 generations on · 0 of its ownK183142 PathVisionXLFaxitron Bioptics, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012 · cites it directly4descendants
- K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017 · 2 generations on2descendants
- K173309Faxitron VisionCTFaxitron Bioptics, LLC · 2018 · 3 generations on1descendant
- K192939Volumetric Specimen ImagerClarix Imaging · 2019 · 4 generations on0descendants
- K183142PathVisionXLFaxitron Bioptics, LLC · 2019 · 2 generations on0descendants
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) | K072557 | Faxitron Specimen Radiography System, Model MX-20 | Faxitron X-Ray Corp. | 2007 | — |
| +1 | K122428 | Faxitron Specien Radiography System | Faxitron Bioptics, LLC | 2012 | — |
| +2 | K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017 | — |
| +3 | K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018 | — |
| +4 | K192939 | Volumetric Specimen Imager | Clarix Imaging | 2019 | — |
| +2 | K183142 | PathVisionXL | Faxitron Bioptics, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K852634 | Micro-Focus 50 Cabinet X-RaySummary page 1…System is substantially equivalent to the following to the following predicate devices: o Faxitron Micro 50 Specimen Radiography System-K852634 o Faxitron DX-50 Digital Radiography System-K061361 Faxitron X-ray Corporation MX-20 510(k) Submission… | 1985 |
| * | K061361 | Faxitron Digital Radiography System, Model DX-50Summary page 1…following predicate devices: o Faxitron Micro 50 Specimen Radiography System-K852634 o Faxitron DX-50 Digital Radiography System-K061361 Faxitron X-ray Corporation MX-20 510(k) Submission Page 9 of 30… | 2006 |
| * | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) SystemSummary page 2…= Page 2 === K079 5 o piXarray Digital Specimen Radiography System-K052433 B. DEVICE DESCRIPTION - as required by 21 CFR 807.92(a)(4) The Faxitron MX-20 Specimen Radiography System is a… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122428 | Faxitron Specien Radiography System | 2012 | 4 |
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, K122428 (Faxitron Bioptics, LLC, 2012) has gone furthest, with 4 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. 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?
The MX-20 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/K072557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072557: Faxitron Specimen Radiography System, Model MX-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072557
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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