Product code EAM
- Device name
- Screen, Intensifying, Radiographic
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1960
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974423 | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL | Sterling Diagnostic Imaging, Inc. | 1997-12-22 |
| K963913 | MD100 & MM150 | Konica Medical Corp. | 1997-10-08 |
| K954161 | JPI INTENSIFYING SCREEN | Jpi Healthcare Co, Ltd. | 1996-02-02 |
| K943823 | FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 |
| K943822 | FUJI UM MAMMO SERIES INTENSIFY SCREENS: | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 |
| K943821 | KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC | Fujifilm Medical System U.S.A., Inc. | 1994-08-22 |
| K943425 | FUJI HG-M INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | 1994-08-17 |
| K942235 | KYOKKO GREEN SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | 1994-08-17 |
| K942805 | KYOKKO BLUE SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | 1994-07-29 |
| K942909 | KODAK INSIGHT TWIN-LOAD INSERT | Eastman Kodak Company | 1994-07-29 |
| K942399 | KYOKKO UM SERIES INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | 1994-06-10 |
| K941023 | RAREX GREEN FAST | Mci Optonix, Inc. | 1994-03-30 |
| K933161 | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN | Dupont Medical Products | 1993-10-07 |
| K931283 | MICROVISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1993-06-08 |
| K920200 | ULTRA-VISION DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-28 |
| K920190 | ULTRA-VISION RAPID INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-28 |
| K920194 | ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1992-05-27 |
| K896707 | PERLINK SCREEN, KIRAN SCREEN | Perlink USA, Inc. | 1990-08-30 |
| K902039 | RAREX & OPTEX X-RAY SCREENS | Mci Optonix, Inc. | 1990-07-27 |
| K901014 | RADIOGRAPHIC INTENSIFYING SCREEN | Infab Corp. | 1990-04-02 |
| K900448 | CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-16 |
| K900318 | CRONEX QUANTA SUPER RAPID SR339 RARE EARTH | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-05 |
| K900103 | CRONEX QUANTA SR300 INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-05 |
| K893510 | CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | 1989-06-23 |
| K873167 | KODAK MIN-R MEDIUM SCREEN | Eastman Kodak Company | 1987-08-27 |
| K862414 | FUJI CR IMAGING PLATE | Parexel Intl. Corp. | 1987-02-26 |
| K860755 | KODAK MIN-R FAST SCREEN SO-459 | Eastman Kodak Company | 1986-03-06 |
| K845030 | CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS | E.I. Dupont DE Nemours & Co., Inc. | 1985-02-26 |
| K834484 | CRONEX SR-337 | E.I. Dupont DE Nemours & Co., Inc. | 1984-02-21 |
| K813147 | KODAK INTENSIFYING SCREEN 80-175 | Eastman Kodak Company | 1981-12-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 40192155942538 | CS 7600 Smart Plate | CARESTREAM DENTAL LLC | 2020-02-17 |
| 40192155942545 | CS 7600 Smart Plate | CARESTREAM DENTAL LLC | 2020-02-17 |
| 40192155942552 | CS 7600 Smart Plate | CARESTREAM DENTAL LLC | 2020-02-17 |
| 40192155942569 | CS 7600 Smart Plate | CARESTREAM DENTAL LLC | 2020-02-17 |
| 40192155942514 | CS 7600 Smart Plate | CARESTREAM DENTAL LLC | 2020-02-17 |
| 40192155942583 | Imaging Plate | CARESTREAM DENTAL LLC | 2020-02-13 |
| 40192155942590 | Imaging Plate | CARESTREAM DENTAL LLC | 2019-12-13 |
| 40192155942606 | Imaging Plate | CARESTREAM DENTAL LLC | 2019-12-13 |
| 40889971337050 | Imaging Plate for CS 7200 | CARESTREAM HEALTH, INC. | 2018-06-29 |
| 40889971067551 | Imaging Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971423166 | Flexible Phosphor Screen GP-2 | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971067568 | Imaging Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971098913 | Imaging Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971117034 | MIN-R 2 Cassette with MIN-R EV 150 Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971207377 | LANEX Regular Screens | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971220703 | LANEX Fine Screens | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971267623 | LANEX Fine Screens | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971340074 | Imaging Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971414683 | LANEX Regular Screens | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971067544 | Imaging Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971060019 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971059990 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971059983 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971059969 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971059952 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971014463 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971014456 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971014449 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971014432 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971014425 | CS 7600 Smart Plate | CARESTREAM HEALTH, INC. | 2016-09-16 |