EAM · Screen, Intensifying, Radiographic
Radiology · 21 CFR 892.1960 · Class 1
Overview
| Product Code | EAM |
|---|---|
| Device Name | Screen, Intensifying, Radiographic |
| Regulation | 21 CFR 892.1960 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974423 | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL | Sterling Diagnostic Imaging, Inc. | Dec 22, 1997 | SESE |
| K963913 | MD100 & MM150 | Konica Medical Corp. | Oct 8, 1997 | SESE |
| K954161 | JPI INTENSIFYING SCREEN | Jpi Healthcare Co, Ltd. | Feb 2, 1996 | SESE |
| K943823 | FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 | Fujifilm Medical System U.S.A., Inc. | Aug 22, 1994 | SESE |
| K943822 | FUJI UM MAMMO SERIES INTENSIFY SCREENS: | Fujifilm Medical System U.S.A., Inc. | Aug 22, 1994 | SESE |
| K943821 | KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC | Fujifilm Medical System U.S.A., Inc. | Aug 22, 1994 | SESE |
| K943425 | FUJI HG-M INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | Aug 17, 1994 | SESE |
| K942235 | KYOKKO GREEN SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | Aug 17, 1994 | SESE |
| K942909 | KODAK INSIGHT TWIN-LOAD INSERT | Eastman Kodak Company | Jul 29, 1994 | SESE |
| K942805 | KYOKKO BLUE SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | Jul 29, 1994 | SESE |
| K942399 | KYOKKO UM SERIES INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | Jun 10, 1994 | SESE |
| K941023 | RAREX GREEN FAST | Mci Optonix, Inc. | Mar 30, 1994 | SESE |
| K933161 | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN | Dupont Medical Products | Oct 7, 1993 | SESE |
| K931283 | MICROVISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | Jun 8, 1993 | SESE |
| K920200 | ULTRA-VISION DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | May 28, 1992 | SESE |
| K920190 | ULTRA-VISION RAPID INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | May 28, 1992 | SESE |
| K920194 | ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | May 27, 1992 | SESE |
| K896707 | PERLINK SCREEN, KIRAN SCREEN | Perlink USA, Inc. | Aug 30, 1990 | SESE |
| K902039 | RAREX & OPTEX X-RAY SCREENS | Mci Optonix, Inc. | Jul 27, 1990 | SESE |
| K901014 | RADIOGRAPHIC INTENSIFYING SCREEN | Infab Corp. | Apr 2, 1990 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 11 clearances
- Fujifilm Medical System U.S.A., Inc. — 7 clearances
- Eastman Kodak Company — 7 clearances
- Mci Optonix, Inc. — 2 clearances
- Sterling Diagnostic Imaging, Inc. — 1 clearance
