# K210151: Digimamo D

- Pathway: 510(k) (Traditional)
- Applicant: Vmi Tecnologias Ltda
- Decided: Mar 1, 2022 after 404 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: 2 generations back to P010017 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172027: Adani MammoScan, Adani (2017) Summary page 4.

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

Source page: https://510kreport.com/device/K210151
Methodology: https://510kreport.com/methodology