# K964069: Dsbas Option the Mammomat 3000 Mammography X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 8, 1997 after 210 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mammovision: named in the summary without a submission number
- (no number) DSM: named in the summary without a submission number

## Indications for use
The Siemens Digital Stereotactic Biopsy Attachment System (DSBAS) marketed as OPDIMA (Optimized Digital Mammography) is a digital small field x-ray option for the commercially available Mammomat 3000 mammographic x-ray system. The Mammomat 3000 with DSBAS option is intended for use in small field mammographic x-ray imaging. Such small field imaging is used during stereotactic biopsy and spot localization.

Source page: https://510kreport.com/device/K964069
Methodology: https://510kreport.com/methodology