Cleared Traditional

LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE

K013229 · Ferrania USA, Inc. · Radiology

Oct 2001

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K013229 is an FDA 510(k) clearance for the LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE, a Cassette, Radiographic Film (Class II — Special Controls, product code IXA), submitted by Ferrania USA, Inc. (Weatherford, US). The FDA issued a Cleared decision on October 12, 2001, 15 days after receiving the submission on September 27, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.

Submission Details

510(k) Number	K013229 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2001
Decision Date	October 12, 2001
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF