# K861692: Fischer PPS/Mammotest Mammography System

- Pathway: 510(k) (Traditional)
- Applicant: Fischer Imaging Corp.
- Decided: Dec 15, 1986 after 227 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
154 later devices descend from it; 2 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984298: Z Kat Flurotactic Guidance System Mki (1999), 152 descendants of its own
- K013025: Modification to Flourolab Plus (2001), 151 descendants of its own
- K031454: Acumen Surgical Navigation System (2004), 146 descendants of its own
- K031337: Acumen Surgical Navigation System (2003), 81 descendants of its own
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own

## Recalls of this device
- Jul 9, 2004 · Not classified · Z-0379-05: X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.

Source page: https://510kreport.com/device/K861692
Methodology: https://510kreport.com/methodology