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HOLOGIC INC

SECURVIEW · Radiology

510(k): 3 Recall: 1 UDI: 2 MAUDE: 0 Class.: 10

510(k) Clearances (3)

SECURVIEW DX DIAGNOSTIC WORKSTATION
2011-02-02

Substantially Equivalent

SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
2006-08-18

Substantially Equivalent

SECURVIEW DX SOFTCOPY WORKSTATION
2004-08-09

Substantially Equivalent

Recalls (1)

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
2012-02-28

SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images

UDI Registrations (2)

SecurView Diagnostic Workstation

The SecurView® DX diagnostic workstation software is an application that displays images on mammography review workstations for use by radiologists in the interpretation of images acquired from mammography and digital breast tomosynthesis.

SecurView DX Manager

The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations.

FDA Classification (10)

System, Image Management, Ophthalmic

Radiology

Controller, Temperature, Radiographic

Radiology

Film, Radiographic

Radiology

Instrument, Quality-Assurance, Radiologic

Radiology

Collimator, High Voltage, Therapeutic X-Ray

Radiology

System, Therapeutic, X-Ray

Radiology

Colon Computed Tomography System, Computer Aided Detection

Radiology

Radiation Therapy Marking Device

Radiology

Collimator, Automatic, Radiographic

Radiology

System, Radiation Therapy, Radionuclide

Radiology