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510(k) K943822

Device
FUJI UM MAMMO SERIES INTENSIFY SCREENS:
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
510(k) number
K943822
Product code
EAM  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-22
Date received
1994-06-15
Regulation
892.1960
Classification name
Screen, Intensifying, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT A UZENOFF
Address
333 Ludlow St. P.O. Box 120035 Stamford CT US 06912 06912

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EAM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILSterling Diagnostic Imaging, Inc.1997-12-22
K963913MD100 & MM150Konica Medical Corp.1997-10-08
K954161JPI INTENSIFYING SCREENJpi Healthcare Co, Ltd.1996-02-02
K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., Inc.1994-08-22
K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm Medical System U.S.A., Inc.1994-08-22
K943425FUJI HG-M INTENSIFYING SCREENFujifilm Medical System U.S.A., Inc.1994-08-17
K942235KYOKKO GREEN SERIES INTENSIFYING SCREENSFujifilm Medical System U.S.A., Inc.1994-08-17
K942805KYOKKO BLUE SERIES INTENSIFYING SCREENSFujifilm Medical System U.S.A., Inc.1994-07-29
K942909KODAK INSIGHT TWIN-LOAD INSERTEastman Kodak Company1994-07-29
K942399KYOKKO UM SERIES INTENSIFYING SCREENFujifilm Medical System U.S.A., Inc.1994-06-10
K941023RAREX GREEN FASTMci Optonix, Inc.1994-03-30
K933161ULTRA-VISION SUPER RAPID INTENSIFYING SCREENDupont Medical Products1993-10-07
K931283MICROVISION FAST DETAIL INTENSIFYING SCREENE.I. Dupont DE Nemours & Co., Inc.1993-06-08
K920200ULTRA-VISION DETAIL INTENSIFYING SCREENE.I. Dupont DE Nemours & Co., Inc.1992-05-28
K920190ULTRA-VISION RAPID INTENSIFYING SCREENE.I. Dupont DE Nemours & Co., Inc.1992-05-28

Legacy Summary#

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FDA Review#

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