# K103385: Securview DX Diagnostic Workstation

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Feb 2, 2011 after 76 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 7 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062107: Securview DX Diagnostic Workstation, Models SV-0001, SV-0002 and SV-0003, Hologic, Inc. (2006) Summary page 1.

## Most influential descendants
- K140960: Picture Archiving and Communications System (2014), 3 descendants of its own
- K190694: Unifi Workspace v1.0.0 (2019), 2 descendants of its own
- K123575: Mammoworkstation (2013), 2 descendants of its own
- K220767: TeleScan (2022), 1 descendant of its own
- K143361: Mammo Workstation (2015), 1 descendant of its own

## Recalls of this device
- Feb 28, 2012 · Not classified · Z-1370-2012: SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images

## Indications for use
The Hologic Securiew DX is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards. The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image. The Securiew DX is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.

Source page: https://510kreport.com/device/K103385
Methodology: https://510kreport.com/methodology