Product Code: IXA FDA class 2 21 CFR 892.1850

Cassette, Radiographic Film

Radiology

A radiographic film cassette is a flat, light-tight holder that secures radiographic film in position for exposure, often incorporating intensifying screens to improve image quality and reduce patient radiation dose. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXA, regulated under 21 CFR 892.1850, within the Radiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: IXA
Device Class: FDA class 2
Regulation Number: 892.1850
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 51 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K081557	PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER	Sep 10, 2008	Substantially Equivalent	Jddb Manufacturing, Inc.
K053173	DS CASSETTE	Dec 15, 2005	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K040378	KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253	May 24, 2004	Substantially Equivalent	Eastman Kodak Company
K023020	AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE	Sep 26, 2002	Substantially Equivalent	Agfa Corp.
K021903	KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE	Jul 10, 2002	Substantially Equivalent	Eastman Kodak Company
K013686	KODAK DIRECTVIEW TABLETOP CASSETTE	Dec 07, 2001	Substantially Equivalent	Eastman Kodak Company
K013229	LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE	Oct 12, 2001	Substantially Equivalent	Ferrania USA, Inc.
K012373	LIFERAY WL CASSETTE, LIFERAY KW CASSETTE	Aug 09, 2001	Substantially Equivalent	Ferrania S.P.A.
K983918	RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)	Mar 12, 1999	Substantially Equivalent	Mastek, Inc.
K980722	TRIMAX RADIOGRAPHIC CASSETTE	Mar 23, 1998	Substantially Equivalent	Imation Corp.
K963914	CM & CM DS-7	Oct 08, 1997	Substantially Equivalent	Konica Medical Corp.
K971431	UMI X-RAY FILM CASSETTE	May 20, 1997	Substantially Equivalent	Umi Intl.
K970090	SOLO-SLED	Apr 21, 1997	Substantially Equivalent	Solo-Sled, LLC
K961453	KODAK MN-R 2000 CASSETTE	Jul 25, 1996	Substantially Equivalent	Eastman Kodak Company
K962336	RADIOGRAPHIC FILM CASSETTES	Jul 03, 1996	Substantially Equivalent	Unidex Group, Inc.
K953725	CRONEX RADIATION THERAPY VERIFICATION CASSETTE	Sep 06, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K953724	CRONEX RADIATION THERAPY CASSETTE	Sep 06, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K953444	MCI OPTONIX ECONOMY CASSETTE	Aug 02, 1995	Substantially Equivalent	Mci Optonix, Inc.
K952891	CRONEX LOW ABSORPTION CASSETTE	Jul 13, 1995	Substantially Equivalent	The DU Pont Co.
K951006	KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)	Apr 03, 1995	Substantially Equivalent	Kenex , Ltd.
K945858	X-RAY FILM CASSETTE	Mar 21, 1995	Substantially Equivalent	J.P.I. Chicago Co.
K945328	JPI X-RAY FILM CASSETTE	Jan 20, 1995	Substantially Equivalent	Jpi America, Inc.
K945039	MCI OPTONIX CASSETTE OKAMOTO CASSETE	Nov 22, 1994	Substantially Equivalent	Mci Optonix, Inc.
K941600	MT-300 CASSETTE HOLDER	Sep 16, 1994	Substantially Equivalent	Medtec, Inc.
K942481	FUJI ULTIMA EC-MA CASSETTE	Jul 29, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K941475	CRONEX REGULAR CASSETTE	Jul 20, 1994	Substantially Equivalent	Dupont Medical Products
K941518	DUPONT CRONEX PORTABLE GRID CASSETTE	Jun 06, 1994	Substantially Equivalent	Dupont Medical Products
K935397	NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS	Dec 15, 1993	Substantially Equivalent	Victoreen, Inc.
K932565	FUJIFILM EC-B SERIES CASETTE	Jul 26, 1993	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K931074	DU PONT MV DARKROOM CASSETTE	Jun 08, 1993	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K930220	CASSETTE, RADIOGRAPHIC FILM	Apr 13, 1993	Substantially Equivalent	X-Ray Accessories Mfg. Co.
K930244	JPI X-RAY FILM CASSETTE	Apr 07, 1993	Substantially Equivalent	Jpi, Inc.
K923334	MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER	Jan 26, 1993	Substantially Equivalent	Cook, Inc.
K921826	KODAK INSIGHT PORTABLE IMAGING SYSTEM	Aug 26, 1992	Substantially Equivalent	Eastman Kodak Company
K911041	INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE	Jun 04, 1991	Substantially Equivalent	Invotec International, Inc.
K896708	PERLINK CASSETTE, KIRAN CASSETTE	May 07, 1990	Substantially Equivalent	Perlink USA, Inc.
K901013	RADIOGRAPHIC FILM CASSETTE	Mar 28, 1990	Substantially Equivalent	Infab Corp.
K900620	DU PONT MAMMOGRAPHY CASSETTE	Feb 26, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K895335	CRONEX COMPACT MAMMOGRAPHY CASSETTE	Feb 16, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K893728	PINK CASSETTE CADDIE	Sep 18, 1989	Substantially Equivalent	Medical Technique Instruments, Inc.
K890750	KODAK X-OMATIC RA CASSETTE	Mar 01, 1989	Substantially Equivalent	Eastman Kodak Company
K890361	KODAK MIN-R 2 CASSETTE	Feb 24, 1989	Substantially Equivalent	Eastman Kodak Company
K885178	KODAFLEX II RADIATION THERAPY L CASSETTE	Feb 03, 1989	Substantially Equivalent	Eastman Kodak Company
K883312	L-F/KODAK FLEXIBLE GRID CASSETTE	Aug 16, 1988	Substantially Equivalent	Mallinckrodt Group, Inc.
K875083	KODAK KODAFLEX II CASSETTE	Jan 19, 1988	Substantially Equivalent	Eastman Kodak Company
K860754	KODAK T-MAT M FILM SO-245	Mar 06, 1986	Substantially Equivalent	Eastman Kodak Company
K850415	CRONEX KEVLAR CASSETTE	May 14, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K843176	KODAK X-OMATIC RADIATION THERAPY CASS	Aug 27, 1984	Substantially Equivalent	Eastman Kodak Company
K812535	PLASTILIX MINIRAD D CASSETTE	Oct 19, 1981	Substantially Equivalent	Eastman Kodak Company
K792721	HUESTIS FLEXI-HOLDER	Feb 19, 1980	Substantially Equivalent	Huestis Machine Corp.
K771682	MIN-R CASSETTE	Sep 20, 1977	Substantially Equivalent	Eastman Kodak Company