# K172027: Adani MammoScan

- Pathway: 510(k) (Traditional)
- Applicant: Adani
- Decided: Oct 20, 2017 after 107 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P010017 (2001). 1 ancestor in all.
1 later device descends 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)
- P010017: Senoscan Full Field Digital Mammography System, Hologic, Inc. (2001) Summary page 4.

## Most influential descendants
- K210151: Digimamo D (2022), 0 descendants of its own

## Indications for use
The MammoScan® Full-Field Digital Mammography System is a device intended to produce planar digital x-ray images of the entire breast. The MammoScan is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoScan is intended to be used in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K172027
Methodology: https://510kreport.com/methodology