510(k) · Cleared
Recalled · 2004Fischer PPS/Mammotest Mammography System
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 Dec 15, 1986 after a 227-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 154 later devices descend from it. It has been recalled once.
- Decided
- Dec 15, 1986
- Review
- 227 days
- Class
- Class II
- Product code
- IZH
- Recalls
- 1
- Predicates
- 0
154 later devices descend from it, 2 citing it directly.
- This deviceK861692 Fischer PPS/Mammotest Mammography SystemFischer Imaging Corp. · 1986
- Descendant · cites it directly · 152 of its ownK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- Descendant · 2 generations on · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- Descendant · 3 generations on · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- Descendant · 3 generations on · 81 of its ownK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- Descendant · 4 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
Showing 5 of 154 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 154 · See all- K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999 · cites it directly152descendants
- K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · 2 generations on151descendants
- K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 3 generations on146descendants
- K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · 3 generations on81descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 4 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861692 | Fischer PPS/Mammotest Mammography System | Fischer Imaging Corp. | 1986 | — |
| +1 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| +2 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| +3 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| +3 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| +4 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 2 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (154)
See all 1542 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2004 | Not classified | Z-0379-05 | Other | X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984298 (Z-Kat, Inc., 1999) has gone furthest, with 152 descendants of its own.
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 | — |
https://510kreport.com/device/K861692 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861692: Fischer PPS/Mammotest Mammography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861692
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026