TABLE 6-6 FDA Device Approvals for Breast Cancer Detection from 1995-2004*

Device Type

Device Name

Company

Approval Date

Approved Use

Digital mammography system

Lorad Digital Breast Imager

Holologic, Inc.

03/15/2002

Screening and diagnosis of breast cancer

SensoScan FFDM

Fischer Imaging Corp.

09/25/2001

Senographe 2000D FFDM

GE Medical Systems

01/28/2000

CAD system

Second LookTM

MammoReader

M1000 Image Checker

Qualia Computing, Inc.

iCAD, Inc.

R2 Technology, Inc.

01/31/2002

01/15/2002

06/26/1998

Identify areas on mammogram that may warrant a second review

Ductal lavage

DucPrepTM Breast

ProDuct Catheter

Windy Hill Technology, Inc. Aspirator

ProDuct Health, Inc.

04/10/2000

12/23/1999

Collection of breast duct fluid for subsequent cytological evaluation

Infrared imaging

BreastScanIRTM

BioScanIR® Technologies, Inc.

Infrared Sciences Corp.

OmniCorder

2/20/2004

12/23/1999

Adjunct to mammography for breast cancer diagnosis and for detecting diseases that affect blood flow

Electrical impedance scanner

T-Scan 2000

TransScan Medical, Inc.

04/16/1999

Adjunct to mammography in patients with BI-RADS® 3 or 4

Pulsed doppler ultrasound system

Ultramark 9 HDI

Ultrasound System

Advanced Technology Laboratories, Inc.

04/11/1996

Determine whether biopsy is needed in breast lumps over 1 cm in diameter

Diagnostic test (radioimmunoassay)

Truquant® BR™ RIA

Biomira, Inc.

03/29/1996

Blood test used in conjunction with other procedures to monitor the recurrence of Stage II or Stage III breast cancer



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