Cleared Traditional

K090223 - ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 (FDA 510(k) Clearance)

K090223 · Icad, Inc. · Radiology device

Mar 2009

Decision

60d

Days

Class 2

Risk

K090223 is an FDA 510(k) clearance for the ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Icad, Inc. (Nashua, US). The FDA issued a Cleared decision on March 31, 2009, 60 days after receiving the submission on January 30, 2009.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K090223 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 30, 2009
Decision Date	March 31, 2009
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF