Feb

2009

Cl Il CAD Sciences LLC 3 TP

Company: iCAD, Inc.
Date of Enforcement Report 2/4/2009
Class:ll

PRODUCT
a) CAD SCIENCES LLC 3 TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. Recall # Z-0653-2009;
b) CAD SCIENCES LLC 3 TP PrecisionPointTM Software, for biopsy guidance. Recall # Z-0654-2009;

REASON
Software modules not approved for this indication.

RECALLING FIRM/MANUFACTURER
iCAD, Inc., Nashua, NH, by telephone and letter on December 5, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
35 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il CAD Sciences LLC 3 TP

Amy Sellers

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