FDA.report

510(k) K013229

Device
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
Applicant
Ferrania USA, Inc.
510(k) number
K013229
Product code
IXA
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-12
Date received
2001-09-27
Regulation
892.1850
Classification name
Cassette, Radiographic Film
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Related Records

Applicant Contact

Contact
DOUG HALE
Address
2700 E. Frontage Rd. Weatherford OK US 73096 73096

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K013686KODAK DIRECTVIEW TABLETOP CASSETTEEastman Kodak Company2001-12-07
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K963914CM & CM DS-7Konica Medical Corp.1997-10-08
K971431UMI X-RAY FILM CASSETTEUmi Intl.1997-05-20
K970090SOLO-SLEDSolo-Sled, LLC1997-04-21
K961453KODAK MN-R 2000 CASSETTEEastman Kodak Company1996-07-25
K962336RADIOGRAPHIC FILM CASSETTESUnidex Group, Inc.1996-07-03
K953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEE.I. Dupont DE Nemours & Co., Inc.1995-09-06