# P030010: Siemens Mammomat Novationdr Full Field Digital Mammography System

- Pathway: PMA
- Applicant: Siemens Medical Solution
- Decided: Aug 20, 2004 after 498 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 6 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K123520: Mammomat Inspiration Prime (2013), 7 descendants of its own
- K042868: Mammoreport Softcopy Workstation (2005), 7 descendants of its own
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K110729: Aspire HD Full-Field Digital Mammography System (2011), 5 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own

## Recalls of this device
- Jan 23, 2009 · Not classified · Z-1233-2009: Image may appear dark, requiring repeat image acquisition.
- May 25, 2005 · Not classified · Z-1045-05: potential issue (image acquisition may become interrupted) when using multiple network nodes

Source page: https://510kreport.com/device/P030010
Methodology: https://510kreport.com/methodology