# P010017: Senoscan Full Field Digital Mammography System

- Pathway: PMA
- Applicant: Hologic, Inc.
- Decided: Sep 25, 2001 after 196 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K172027: Adani MammoScan (2017), 1 descendant of its own
- K210151: Digimamo D (2022), 0 descendants of its own

## Recalls of this device
- May 21, 2004 · Not classified · Z-1094-04: Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
- Apr 12, 2004 · Not classified · Z-0939-04: X-ray tube may overheat after high usage because of mis-wired thermal switch circuit.

Source page: https://510kreport.com/device/P010017
Methodology: https://510kreport.com/methodology