510(k) · Cleared
ClearedMammopath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer Imaging Corp. · MWP Cabinet, X-Ray System
Cleared on Jun 13, 2002 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.
- Decided
- Jun 13, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 2 citing it directly.
- This deviceK021113 MammopathFischer Imaging Corp. · 2002
- Descendant · cites it directly · 25 of its ownK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- Descendant · 2 generations on · 18 of its ownK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
- Descendant · 3 generations on · 15 of its ownK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
- Descendant · 4 generations on · 14 of its ownK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
- Descendant · 2 generations on · 7 of its ownK091558 Biovision Digital Specimen Radiography SystemBioptics, Inc. · 2009
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K052433Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005 · cites it directly25descendants
- K071233Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007 · 2 generations on18descendants
- K083510Kubtec Xpert 20Kub Technologies, Inc. · 2009 · 3 generations on15descendants
- K111508Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011 · 4 generations on14descendants
- K091558Biovision Digital Specimen Radiography SystemBioptics, Inc. · 2009 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| +1 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| +2 | K071233 | Xpert 40 Specimen Radiography System | Kub Technologies, Inc. | 2007 | — |
| +3 | K083510 | Kubtec Xpert 20 | Kub Technologies, Inc. | 2009 | — |
| +4 | K111508 | Trident Specimen Radiography System, Model : RC Tri-00001 | Hologic, Inc. | 2011 | — |
| +2 | K091558 | Biovision Digital Specimen Radiography System | Bioptics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 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? (27)
See all 272 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, K052433 (Bioptics, Inc., 2005) has gone furthest, with 25 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 MarnnzoPdz can be used with MammotestB (K861692). Mammotest is a breast biopsy system maiiufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopatlz would then be used for digital imaging of…
Read the full statement (143 words)
The MarnnzoPdz can be used with MammotestB (K861692). Mammotest is a breast biopsy system maiiufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopatlz would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy.
The MavlzrnoPatlz can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen.
Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021113 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021113: Mammopath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021113
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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