Atlas FDA

EAM

35 FDA 510(k) clearances · Product code

46 daysmedian time to decision
150 days90th percentile
35clearances measured

FDA profile

Official device name
Screen, Intensifying, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1960
Medical specialty
Radiology
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RecordFirmDate
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (K974423)Sterling Diagnostic Imaging, Inc.1997-12-22
MD100 & MM150 (K963913)Konica Medical Corp.1997-10-08
JPI INTENSIFYING SCREEN (K954161)Jpi Healthcare Co, Ltd.1996-02-02
KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (K943821)Fujifilm Medical System U.S.A., Inc.1994-08-22
FUJI UM MAMMO SERIES INTENSIFY SCREENS: (K943822)Fujifilm Medical System U.S.A., Inc.1994-08-22
FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (K943823)Fujifilm Medical System U.S.A., Inc.1994-08-22
KYOKKO GREEN SERIES INTENSIFYING SCREENS (K942235)Fujifilm Medical System U.S.A., Inc.1994-08-17
FUJI HG-M INTENSIFYING SCREEN (K943425)Fujifilm Medical System U.S.A., Inc.1994-08-17
KYOKKO BLUE SERIES INTENSIFYING SCREENS (K942805)Fujifilm Medical System U.S.A., Inc.1994-07-29
KODAK INSIGHT TWIN-LOAD INSERT (K942909)Eastman Kodak Company1994-07-29
KYOKKO UM SERIES INTENSIFYING SCREEN (K942399)Fujifilm Medical System U.S.A., Inc.1994-06-10
RAREX GREEN FAST (K941023)Mci Optonix, Inc.1994-03-30
ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN (K933161)Dupont Medical Products1993-10-07
MICROVISION FAST DETAIL INTENSIFYING SCREEN (K931283)E.I. Dupont DE Nemours & Co., Inc.1993-06-08
ULTRA-VISION RAPID INTENSIFYING SCREEN (K920190)E.I. Dupont DE Nemours & Co., Inc.1992-05-28
ULTRA-VISION DETAIL INTENSIFYING SCREEN (K920200)E.I. Dupont DE Nemours & Co., Inc.1992-05-28
ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN (K920194)E.I. Dupont DE Nemours & Co., Inc.1992-05-27
PERLINK SCREEN, KIRAN SCREEN (K896707)Perlink USA, Inc.1990-08-30
RAREX & OPTEX X-RAY SCREENS (K902039)Mci Optonix, Inc.1990-07-27
RADIOGRAPHIC INTENSIFYING SCREEN (K901014)Infab Corp.1990-04-02
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN (K900448)E.I. Dupont DE Nemours & Co., Inc.1990-02-16
CRONEX QUANTA SR300 INTENSIFYING SCREEN (K900103)E.I. Dupont DE Nemours & Co., Inc.1990-02-05
CRONEX QUANTA SUPER RAPID SR339 RARE EARTH (K900318)E.I. Dupont DE Nemours & Co., Inc.1990-02-05
CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN (K893510)E.I. Dupont DE Nemours & Co., Inc.1989-06-23
KODAK MIN-R MEDIUM SCREEN (K873167)Eastman Kodak Company1987-08-27
FUJI CR IMAGING PLATE (K862414)Parexel Intl. Corp.1987-02-26
KODAK MIN-R FAST SCREEN SO-459 (K860755)Eastman Kodak Company1986-03-06
CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS (K845030)E.I. Dupont DE Nemours & Co., Inc.1985-02-26
CRONEX SR-337 (K834484)E.I. Dupont DE Nemours & Co., Inc.1984-02-21
KODAK INTENSIFYING SCREEN 80-175 (K813147)Eastman Kodak Company1981-12-14
KODAK INTENSIFYING SCREEN SO-168 (K813139)Eastman Kodak Company1981-12-08
KODAK LANEX MED. SCREEN (K792123)Eastman Kodak Company1979-12-10
SCREEN, FINE, LANES, KODAK (K770837)Eastman Kodak Company1977-05-26
CRONEX QUANTA III INTENSIFYING SCREENS (K770574)E.I. Dupont DE Nemours & Co., Inc.1977-04-05
FLUORICON 500 IMAGE INTENSIFIERS (K770094)General Electric Co.1977-01-21

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Every clearance here is in the API, with alerts when new ones post.