Devices

Device Recall Hologics SecurView DX workstation

Model / Serial
software version 7.3.0 S/N:298051183669, 29703060119, 298031083133, 298120882443, 298090882384, 29803070916, 2981070859
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.
Product Description
Hologics SecurView DX workstation, software version 7.3.0 || intended for viewing mammography images and other imaging modalities. || SecurView DX is intended for selection, display, manipulation, filing and media interchange of multimodality 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 multimodality image.
Manufacturer
Hologic, Inc.
1 Event
- Recall of Device Recall Hologics SecurView DX workstation

Manufacturer

Hologic, Inc.

Manufacturer Address
Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
Manufacturer Parent Company (2017)
Hologic Inc
Source
USFDA

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