Screen, Intensifying, Radiographic
Regulation 892.1960
0510(k)s in 12 months (35 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in EAM
| Company | 510(k)s | Recalls |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 11 | 0 |
| Eastman Kodak Company | 7 | 0 |
| Fujifilm Medical System U.S.A., Inc. | 7 | 0 |
| General Electric Med Systems | 0 | 4 |
| Mci Optonix, Inc. | 2 | 0 |
| Dupont Medical Products | 1 | 0 |
| General Electric Co. | 1 | 0 |
| Infab Corp. | 1 | 0 |
| Jpi Healthcare Co, Ltd. | 1 | 0 |
| Konica Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 1997 | K974423 | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL Sterling Diagnostic Imaging, Inc. | EAM |
| Oct 8, 1997 | K963913 | MD100 & MM150 Konica Medical Corp. | EAM |
| Feb 2, 1996 | K954161 | JPI INTENSIFYING SCREEN Jpi Healthcare Co, Ltd. | EAM |
| Aug 22, 1994 | K943823 | FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 Fujifilm Medical System U.S.A., Inc. | EAM |
| Aug 22, 1994 | K943822 | FUJI UM MAMMO SERIES INTENSIFY SCREENS: Fujifilm Medical System U.S.A., Inc. | EAM |
| Aug 22, 1994 | K943821 | KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC Fujifilm Medical System U.S.A., Inc. | EAM |
| Aug 17, 1994 | K943425 | FUJI HG-M INTENSIFYING SCREEN Fujifilm Medical System U.S.A., Inc. | EAM |
| Aug 17, 1994 | K942235 | KYOKKO GREEN SERIES INTENSIFYING SCREENS Fujifilm Medical System U.S.A., Inc. | EAM |
| Jul 29, 1994 | K942909 | KODAK INSIGHT TWIN-LOAD INSERT Eastman Kodak Company | EAM |
| Jul 29, 1994 | K942805 | KYOKKO BLUE SERIES INTENSIFYING SCREENS Fujifilm Medical System U.S.A., Inc. | EAM |
| Jun 10, 1994 | K942399 | KYOKKO UM SERIES INTENSIFYING SCREEN Fujifilm Medical System U.S.A., Inc. | EAM |
| Mar 30, 1994 | K941023 | RAREX GREEN FAST Mci Optonix, Inc. | EAM |
| Oct 7, 1993 | K933161 | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN Dupont Medical Products | EAM |
| Jun 8, 1993 | K931283 | MICROVISION FAST DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| May 28, 1992 | K920200 | ULTRA-VISION DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| May 28, 1992 | K920190 | ULTRA-VISION RAPID INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| May 27, 1992 | K920194 | ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Aug 30, 1990 | K896707 | PERLINK SCREEN, KIRAN SCREEN Perlink USA, Inc. | EAM |
| Jul 27, 1990 | K902039 | RAREX & OPTEX X-RAY SCREENS Mci Optonix, Inc. | EAM |
| Apr 2, 1990 | K901014 | RADIOGRAPHIC INTENSIFYING SCREEN Infab Corp. | EAM |
| Feb 16, 1990 | K900448 | CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Feb 5, 1990 | K900318 | CRONEX QUANTA SUPER RAPID SR339 RARE EARTH E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Feb 5, 1990 | K900103 | CRONEX QUANTA SR300 INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Jun 23, 1989 | K893510 | CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Aug 27, 1987 | K873167 | KODAK MIN-R MEDIUM SCREEN Eastman Kodak Company | EAM |
| Feb 26, 1987 | K862414 | FUJI CR IMAGING PLATE Parexel Intl. Corp. | EAM |
| Mar 6, 1986 | K860755 | KODAK MIN-R FAST SCREEN SO-459 Eastman Kodak Company | EAM |
| Feb 26, 1985 | K845030 | CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Feb 21, 1984 | K834484 | CRONEX SR-337 E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Dec 14, 1981 | K813147 | KODAK INTENSIFYING SCREEN 80-175 Eastman Kodak Company | EAM |
| Dec 8, 1981 | K813139 | KODAK INTENSIFYING SCREEN SO-168 Eastman Kodak Company | EAM |
| Dec 10, 1979 | K792123 | KODAK LANEX MED. SCREEN Eastman Kodak Company | EAM |
| May 26, 1977 | K770837 | SCREEN, FINE, LANES, KODAK Eastman Kodak Company | EAM |
| Apr 5, 1977 | K770574 | CRONEX QUANTA III INTENSIFYING SCREENS E.I. Dupont DE Nemours & Co., Inc. | EAM |
| Jan 21, 1977 | K770094 | FLUORICON 500 IMAGE INTENSIFIERS General Electric Co. | EAM |
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