510(k) · Cleared
ClearedTrident Specimen Radiography System, Model : RC Tri-00001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · MWP Cabinet, X-Ray System
Cleared on Aug 19, 2011 as substantially equivalent to K083510 (Kub Technologies, Inc., 2009) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 2002. 14 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K021113 (2002). 6 ancestors in all, the oldest K953404 (1995). 14 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 3 generations backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- 2 generations backK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- 1 generation backK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- This deviceK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
- Descendant · cites it directly · 3 of its ownK182727 Trident HD Specimen Radiography SystemHologic, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK202713 TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd · 2020
- 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012 · cites it directly4descendants
- K182727Trident HD Specimen Radiography SystemHologic, Inc. · 2019 · cites it directly3descendants
- K202713TrueView 100 ProCompai Healthcare (Shenzhen) Co.,Ltd · 2020 · 2 generations on2descendants
- K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017 · 2 generations on2descendants
- K173309Faxitron VisionCTFaxitron Bioptics, LLC · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −3 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| −2 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| −1 | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| 0 (this device) | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| +1 | K122428 | Faxitron Specien Radiography System | Faxitron Bioptics, LLC | 2012 | — |
| +1 | K182727 | Trident HD Specimen Radiography System | Hologic, Inc. | 2019 | — |
| +2 | K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | 2020 | — |
| +2 | K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017 | — |
| +3 | K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K083510 | Kubtec Xpert 20Summary page 1…Telephone Number: 781-999-7558 Fax Number: 866- 652-8674 Date Prepared: May 27, 2011 Predicate Devices: K083 510 Kubtec XPERT 40 Specimen Radiography System K061361 Faxitron DX-50 Specimen Radiography System Device Description: The… | 2009 |
| * | K061361 | Faxitron Digital Radiography System, Model DX-50Summary page 1…Fax Number: 866- 652-8674 Date Prepared: May 27, 2011 Predicate Devices: K083 510 Kubtec XPERT 40 Specimen Radiography System K061361 Faxitron DX-50 Specimen Radiography System Device Description: The Trident Specimen Radiography System is a self-contained… | 2006 |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122428 | Faxitron Specien Radiography System | 2012 | 4 |
| K182727 | Trident HD Specimen Radiography System | 2019 | 3 |
| K163052 | Brevera Biopsy System with Corlumina Imaging Technology | 2017 | 1 |
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | 2021 | 0 |
| K210957 | Kubec Xpert 80 Radiography System | 2021 | 0 |
| K210956 | Kubtec Mozart (XPERT42) | 2021 | 0 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 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. 2011, 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?
A cabinet x-ray system used to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111508: Trident Specimen Radiography System, Model : RC Tri-00001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111508
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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