# K083740: Mammodiagnost VU

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Feb 13, 2009 after 59 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063267: Isite Pacs, V 4. X, Stentor Inc., A Philips Medical Systems Co. (2006) Summary page 2.
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 2.
- (no number) Hologic SecurView DX: named in the summary without a submission number

## Indications for use
Philips MammoDiagnost VU workstation software package is intended for viewing, manipulation, reporting and communication of digital mammography images (DICOM “For Presentation” images) as well as other modality images. It interfaces to mammography acquisition stations and image storage, printing and CAD devices using DICOM or similar interface standards. Philips MammoDiagnost VU is used with high-resolution monitors for diagnostic mammography. In the USA these monitors must be FDA cleared.

Source page: https://510kreport.com/device/K083740
Methodology: https://510kreport.com/methodology