FDA Product Code
FDA Product Code EAM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1960
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974423 | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL | Sterling Diagnostic Imaging, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K963913 | MD100 & MM150 | Konica Medical Corp. | 1997-10-08 | Traditional | PDF ↗ |
| K954161 | JPI INTENSIFYING SCREEN | Jpi Healthcare Co, Ltd. | 1996-02-02 | Traditional | PDF ↗ |
| K943823 | FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 | Traditional | PDF ↗ |
| K943822 | FUJI UM MAMMO SERIES INTENSIFY SCREENS: | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 | Traditional | PDF ↗ |
| K943821 | KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 | Traditional | PDF ↗ |
| K942235 | KYOKKO GREEN SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K943425 | FUJI HG-M INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K942805 | KYOKKO BLUE SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K942909 | KODAK INSIGHT TWIN-LOAD INSERT | Eastman Kodak Company | 1994-07-29 | Traditional | PDF ↗ |
| K942399 | KYOKKO UM SERIES INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K941023 | RAREX GREEN FAST | Mci Optonix, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K933161 | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN | Dupont Medical Products | 1993-10-07 | Traditional | PDF ↗ |
| K931283 | MICROVISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1993-06-08 | Traditional | PDF ↗ |
| K920190 | ULTRA-VISION RAPID INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K920200 | ULTRA-VISION DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K920194 | ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-27 | Traditional | PDF ↗ |
| K896707 | PERLINK SCREEN, KIRAN SCREEN | Perlink USA, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K902039 | RAREX & OPTEX X-RAY SCREENS | Mci Optonix, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901014 | RADIOGRAPHIC INTENSIFYING SCREEN | Infab Corp. | 1990-04-02 | Traditional | PDF ↗ |
| K900448 | CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K900103 | CRONEX QUANTA SR300 INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K900318 | CRONEX QUANTA SUPER RAPID SR339 RARE EARTH | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K893510 | CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K873167 | KODAK MIN-R MEDIUM SCREEN | Eastman Kodak Company | 1987-08-27 | Traditional | PDF ↗ |
| K862414 | FUJI CR IMAGING PLATE | Parexel Intl. Corp. | 1987-02-26 | Traditional | PDF ↗ |
| K860755 | KODAK MIN-R FAST SCREEN SO-459 | Eastman Kodak Company | 1986-03-06 | Traditional | PDF ↗ |
| K845030 | CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS | E.I. Dupont DE Nemours & Co., Inc. | 1985-02-26 | Traditional | PDF ↗ |
| K834484 | CRONEX SR-337 | E.I. Dupont DE Nemours & Co., Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K813147 | KODAK INTENSIFYING SCREEN 80-175 | Eastman Kodak Company | 1981-12-14 | Traditional | PDF ↗ |
| K813139 | KODAK INTENSIFYING SCREEN SO-168 | Eastman Kodak Company | 1981-12-08 | Traditional | PDF ↗ |
| K792123 | KODAK LANEX MED. SCREEN | Eastman Kodak Company | 1979-12-10 | Traditional | PDF ↗ |
| K770837 | SCREEN, FINE, LANES, KODAK | Eastman Kodak Company | 1977-05-26 | Traditional | PDF ↗ |
| K770574 | CRONEX QUANTA III INTENSIFYING SCREENS | E.I. Dupont DE Nemours & Co., Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K770094 | FLUORICON 500 IMAGE INTENSIFIERS | General Electric Co. | 1977-01-21 | Traditional | PDF ↗ |
Product code EAM · Class I · Radiology. Data: openFDA.