Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1960](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1960) → EAM — Screen, Intensifying, Radiographic # EAM · Screen, Intensifying, Radiographic _Radiology · 21 CFR 892.1960 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM ## Overview - **Product Code:** EAM - **Device Name:** Screen, Intensifying, Radiographic - **Regulation:** [21 CFR 892.1960](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1960) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) ## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K974423.md) | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL | Sterling Diagnostic Imaging, Inc. | Dec 22, 1997 | SESE | | [K963913](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K963913.md) | MD100 & MM150 | Konica Medical Corp. | Oct 8, 1997 | SESE | | [K954161](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K954161.md) | JPI INTENSIFYING SCREEN | Jpi Healthcare Co, Ltd. | Feb 2, 1996 | SESE | | [K943823](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K943823.md) | FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 | Fujifilm Medical System U.S.A., Inc. | Aug 22, 1994 | SESE | | [K943822](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K943822.md) | FUJI UM MAMMO SERIES INTENSIFY SCREENS: | Fujifilm Medical System U.S.A., Inc. | Aug 22, 1994 | SESE | | [K943821](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K943821.md) | KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC | Fujifilm Medical System U.S.A., Inc. | Aug 22, 1994 | SESE | | [K943425](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K943425.md) | FUJI HG-M INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | Aug 17, 1994 | SESE | | [K942235](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K942235.md) | KYOKKO GREEN SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | Aug 17, 1994 | SESE | | [K942909](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K942909.md) | KODAK INSIGHT TWIN-LOAD INSERT | Eastman Kodak Company | Jul 29, 1994 | SESE | | [K942805](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K942805.md) | KYOKKO BLUE SERIES INTENSIFYING SCREENS | Fujifilm Medical System U.S.A., Inc. | Jul 29, 1994 | SESE | | [K942399](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K942399.md) | KYOKKO UM SERIES INTENSIFYING SCREEN | Fujifilm Medical System U.S.A., Inc. | Jun 10, 1994 | SESE | | [K941023](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K941023.md) | RAREX GREEN FAST | Mci Optonix, Inc. | Mar 30, 1994 | SESE | | [K933161](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K933161.md) | ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN | Dupont Medical Products | Oct 7, 1993 | SESE | | [K931283](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K931283.md) | MICROVISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | Jun 8, 1993 | SESE | | [K920200](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K920200.md) | ULTRA-VISION DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | May 28, 1992 | SESE | | [K920190](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K920190.md) | ULTRA-VISION RAPID INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | May 28, 1992 | SESE | | [K920194](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K920194.md) | ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN | E.I. Dupont DE Nemours & Co., Inc. | May 27, 1992 | SESE | | [K896707](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K896707.md) | PERLINK SCREEN, KIRAN SCREEN | Perlink USA, Inc. | Aug 30, 1990 | SESE | | [K902039](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K902039.md) | RAREX & OPTEX X-RAY SCREENS | Mci Optonix, Inc. | Jul 27, 1990 | SESE | | [K901014](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM/K901014.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EAM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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