# K072392: Opdima Digital Mammographic X-Ray System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 25, 2007 after 29 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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 K003945 (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)
- K003945: Opdima, Siemens Medical Solutions USA, Inc. (2001) Summary page 1.
- K071015: Opdima Digital Mammographic X-Ray System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Indications for use
The Siemens MAMMOMAT series with OPDIMA option is intended for use in small field mammographic X-ray imaging (SFDM). Such small field imaging is used during stereotactic biopsy and diagnostic spot localization.

Source page: https://510kreport.com/device/K072392
Methodology: https://510kreport.com/methodology