Product Code: EAM FDA class 1 21 CFR 892.1960

Screen, Intensifying, Radiographic

Radiology

The Radiographic Intensifying Screen is an imaging accessory placed in contact with X-ray film inside a cassette to convert X-ray photons into visible light, thereby reducing the radiation dose required to produce a diagnostic-quality radiographic image. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EAM and the applicable regulation is 21 CFR 892.1960, under the Radiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: EAM
Device Class: FDA class 1
Regulation Number: 892.1960
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 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K974423	ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL	Dec 22, 1997	Substantially Equivalent	Sterling Diagnostic Imaging, Inc.
K963913	MD100 & MM150	Oct 08, 1997	Substantially Equivalent	Konica Medical Corp.
K954161	JPI INTENSIFYING SCREEN	Feb 02, 1996	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K943823	FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12	Aug 22, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K943822	FUJI UM MAMMO SERIES INTENSIFY SCREENS:	Aug 22, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K943821	KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC	Aug 22, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K943425	FUJI HG-M INTENSIFYING SCREEN	Aug 17, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K942235	KYOKKO GREEN SERIES INTENSIFYING SCREENS	Aug 17, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K942909	KODAK INSIGHT TWIN-LOAD INSERT	Jul 29, 1994	Substantially Equivalent	Eastman Kodak Company
K942805	KYOKKO BLUE SERIES INTENSIFYING SCREENS	Jul 29, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K942399	KYOKKO UM SERIES INTENSIFYING SCREEN	Jun 10, 1994	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K941023	RAREX GREEN FAST	Mar 30, 1994	Substantially Equivalent	Mci Optonix, Inc.
K933161	ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN	Oct 07, 1993	Substantially Equivalent	Dupont Medical Products
K931283	MICROVISION FAST DETAIL INTENSIFYING SCREEN	Jun 08, 1993	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K920200	ULTRA-VISION DETAIL INTENSIFYING SCREEN	May 28, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K920190	ULTRA-VISION RAPID INTENSIFYING SCREEN	May 28, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K920194	ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN	May 27, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K896707	PERLINK SCREEN, KIRAN SCREEN	Aug 30, 1990	Substantially Equivalent	Perlink USA, Inc.
K902039	RAREX & OPTEX X-RAY SCREENS	Jul 27, 1990	Substantially Equivalent	Mci Optonix, Inc.
K901014	RADIOGRAPHIC INTENSIFYING SCREEN	Apr 02, 1990	Substantially Equivalent	Infab Corp.
K900448	CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN	Feb 16, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K900318	CRONEX QUANTA SUPER RAPID SR339 RARE EARTH	Feb 05, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K900103	CRONEX QUANTA SR300 INTENSIFYING SCREEN	Feb 05, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K893510	CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN	Jun 23, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K873167	KODAK MIN-R MEDIUM SCREEN	Aug 27, 1987	Substantially Equivalent	Eastman Kodak Company
K862414	FUJI CR IMAGING PLATE	Feb 26, 1987	Substantially Equivalent	Parexel Intl. Corp.
K860755	KODAK MIN-R FAST SCREEN SO-459	Mar 06, 1986	Substantially Equivalent	Eastman Kodak Company
K845030	CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS	Feb 26, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K834484	CRONEX SR-337	Feb 21, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K813147	KODAK INTENSIFYING SCREEN 80-175	Dec 14, 1981	Substantially Equivalent	Eastman Kodak Company
K813139	KODAK INTENSIFYING SCREEN SO-168	Dec 08, 1981	Substantially Equivalent	Eastman Kodak Company
K792123	KODAK LANEX MED. SCREEN	Dec 10, 1979	Substantially Equivalent	Eastman Kodak Company
K770837	SCREEN, FINE, LANES, KODAK	May 26, 1977	Substantially Equivalent	Eastman Kodak Company
K770574	CRONEX QUANTA III INTENSIFYING SCREENS	Apr 05, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K770094	FLUORICON 500 IMAGE INTENSIFIERS	Jan 21, 1977	Substantially Equivalent	General Electric Co.