# K130704: Microdose SI

- Pathway: 510(k) (Traditional)
- Applicant: Philips Digital Mammography Sweden AB
- Decided: Dec 13, 2013 after 273 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: 9 generations back to K904519 (1991). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123995: Microdose SI, Philips Digital Mammography Sweden AB (2013) Summary page 1.
- K102556: Volpara, Version 1.3, Matakina Technology Limited (2010) Summary page 2.
- K120472: Quantra, Hologic, Inc. (2012) Summary page 3.

## Indications for use
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K130704
Methodology: https://510kreport.com/methodology