Product Code: IWZ FDA class 1 21 CFR 892.1840

Film, Radiographic

Radiology

Radiographic film is a photosensitive medium used to capture and store X-ray images, consisting of a base material coated with a silver halide emulsion that responds to ionizing radiation to produce a latent image which is then chemically processed. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWZ, regulated under 21 CFR 892.1840, 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: IWZ
Device Class: FDA class 1
Regulation Number: 892.1840
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

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 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K970154	KODAK EKTASIAN HG FILM (EHG-15)	Apr 04, 1997	Substantially Equivalent	Eastman Kodak Company
K954200	VOXGRAM	Sep 29, 1995	Substantially Equivalent	Voxel
K931604	3M MEDICAL DIAGNOSTIC VIDEOCASSETTE	Jul 21, 1993	Substantially Equivalent	3M Health Care, Ltd.
K931605	3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE	Jul 20, 1993	Substantially Equivalent	3M Health Care, Ltd.
K920539	ORWO X-RAY FILM	Jun 30, 1992	Substantially Equivalent	Burkhart Roentgen Intl., Inc.
K884827	KODAK DENTAL BARRIER PAC	Jan 30, 1989	Substantially Equivalent	Eastman Kodak Company
K862944	KODAK CFT FILM SO-141	Aug 12, 1986	Substantially Equivalent	Eastman Kodak Company
K862415	TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM	Jul 01, 1986	Substantially Equivalent	Parexel Intl. Corp.
K860797	MEDICAL X-RAY FILM	Mar 13, 1986	Substantially Equivalent	India-America Trading Co.
K844554	BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG	Feb 21, 1985	Substantially Equivalent	Belmont Equipment Corp.
K840806	FR MEDICAL X-RAY FILM	Apr 24, 1984	Substantially Equivalent	Fr Medical/Fr Chemicals
K840698	POWERMAT VRP-1 X-RAY IMAGING	Mar 16, 1984	Substantially Equivalent	Powers Chemco, Inc.
K834614	WILCOR-XR RP-L MEDICAL FILM	Mar 05, 1984	Substantially Equivalent	Cea America Corp.
K834613	WILCOR-XR RP MEDICAL FILM	Mar 05, 1984	Substantially Equivalent	Cea America Corp.
K834612	WILCOR-XR RP-OG MEDICAL FILM	Feb 27, 1984	Substantially Equivalent	Cea America Corp.
K834611	SINGUL-XR RP NON SCREEN MED. FILM	Feb 21, 1984	Substantially Equivalent	Cea America Corp.
K833234	KODAK T-MAT L FILM SO-387	Oct 28, 1983	Substantially Equivalent	Eastman Kodak Company
K832504	CRONEX LO-DOSE MAMMOGRAPHY	Sep 12, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K813005	KODAK CINEFLUOROGRAPHIC FILM SO-274	Nov 24, 1981	Substantially Equivalent	Eastman Kodak Company
K811352	POLAROID TPX RADIOGRAPHIC FILM	Jun 18, 1981	Substantially Equivalent	Polaroid Corp.
K802171	KODAK ORTHO L FILM	Oct 31, 1980	Substantially Equivalent	Eastman Kodak Company
K800901	KODAK EKTASPEED DENTAL X-RAY FILM	May 20, 1980	Substantially Equivalent	Eastman Kodak Company
K800134	HOPE MODEL 126, AUTO/PROCES., DEN. FLM	May 02, 1980	Substantially Equivalent	Hope Industries, Inc.
K792517	KODAK X-OMAT RP FILM	Jan 09, 1980	Substantially Equivalent	Eastman Kodak Company
K792448	KODAK X-OMAT G FILM	Jan 09, 1980	Substantially Equivalent	Eastman Kodak Company
K792435	KODAK X-OMAT M20 PROCESSOR, MODEL 1	Jan 09, 1980	Substantially Equivalent	Eastman Kodak Company
K792434	KODAK X-OMAT M20 PROCESSOR, MODEL 2	Jan 09, 1980	Substantially Equivalent	Eastman Kodak Company
K792317	SR 301 MEDICAL X-RAY FILM	Jan 09, 1980	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K792293	KODAK ORTHO G FILM	Jan 09, 1980	Substantially Equivalent	Eastman Kodak Company
K792178	KODAK CFN FILM SO-224	Jan 09, 1980	Substantially Equivalent	Eastman Kodak Company
K791360	KODAK ORTHO M FILM	Sep 04, 1979	Substantially Equivalent	Eastman Kodak Company
K790629	KODAK GRAY TONE IMAGING FILM	Apr 23, 1979	Substantially Equivalent	Eastman Kodak Company
K771681	ORTHO H FILM	Sep 14, 1977	Substantially Equivalent	Eastman Kodak Company
K771223	GRAY TONE IMAGING FILM	Jul 14, 1977	Substantially Equivalent	Eastman Kodak Company