510(k) · Cleared
Recalled · 2009Mammotest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fischer Imaging Corp. · IZH System, X-Ray, Mammographic
Cleared on Oct 29, 2004 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Oct 29, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- IZH
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 IZH? 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 IZH device
- #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2009 | Not classified | Z-1318-2009 | Nonconforming Material/Component | Table may unintentionally lift during procedure |
No ancestor or descendant has a Class I recall.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · IZH
64in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZH
15in 2025
MAUDE reports naming product code IZH, 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 | 3 | 30 | 0 | 11 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 3 | 64 | 0 | 9 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To provide a platform to conduct minimally invasive breast biopsy procedures. A biopsy system, which uses x-ray guidance for stereotactic localization, that allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. The tissue removed will require further evaluation through pathological assessment. The system, in combination with the Kuske Breast Applicator Set and the Comfort Catheter System, can…
Read the full statement (125 words)
To provide a platform to conduct minimally invasive breast biopsy procedures.
A biopsy system, which uses x-ray guidance for stereotactic localization, that allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. The tissue removed will require further evaluation through pathological assessment.
The system, in combination with the Kuske Breast Applicator Set and the Comfort Catheter System, can also be used as a table platform to perform Interstitial Brachytherapy procedures. The Kuske Breast Applicator Set and the Comfort Catheter System are stand alone items that do not attach to the system. The table platform is utilized as a means to image the area of interest and to image the template for placement of the catheters.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042095: Mammotest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042095
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026