# K021113: Mammopath

- Pathway: 510(k) (Traditional)
- Applicant: Fischer Imaging Corp.
- Decided: Jun 13, 2002 after 69 days
- Product code: MWP (Cabinet, X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052433: Pixarray 100 Digital Specimen Radiography (DSR) System (2005), 25 descendants of its own
- K071233: Xpert 40 Specimen Radiography System (2007), 18 descendants of its own
- K083510: Kubtec Xpert 20 (2009), 15 descendants of its own
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001 (2011), 14 descendants of its own
- K091558: Biovision Digital Specimen Radiography System (2009), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K021113
Methodology: https://510kreport.com/methodology