Fuji CR Imaging Plate
FDA 510(k) K862414 · Parexel Intl. Corp.
510(k) numberK862414
Submission
- Device name
- Fuji CR Imaging Plate
- Applicant
- Parexel Intl. Corp.
Cambridge, MA, US - Received
- June 25, 1986
- Decision date
- February 26, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974423 | Ultra-Vision Mammography Detail, Ultra-Vision Mammography Fast DetailEAM · Traditional | Sterling Diagnostic Imaging, Inc. | 12/22/1997SE |
| K963913 | MD100 & MM150EAM · Traditional | Konica Medical Corp. | 10/08/1997SE |
| K954161 | Jpi Intensifying ScreenEAM · Traditional | Jpi Healthcare Co, Ltd. | 02/02/1996SE |
| K943823 | Fuji FG Series Intensifying Screens: FG-3-4-8-12EAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 08/22/1994SE |
| K943822 | Fuji Um Mammo Series Intensify Screens:EAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 08/22/1994SE |
| K943821 | Kyokko Spec-Series Intensify Screens-Spec,Super SpecEAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 08/22/1994SE |
| K943425 | Fuji Hg-M Intensifying ScreenEAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 08/17/1994SE |
| K942235 | Kyokko Green Series Intensifying ScreensEAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 08/17/1994SE |
| K942909 | Kodak Insight Twin-Load InsertEAM · Traditional | Eastman Kodak Company | 07/29/1994SE |
| K942805 | Kyokko Blue Series Intensifying ScreensEAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 07/29/1994SE |
More from Fujifilm Medical System U.S.A., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K900385 | Acta Metra/Acta Gnosis Firmware PackageDSI · Traditional | 07/09/1991SE |
| K904902 | Sma 26 TransducerITX · Traditional | 03/26/1991SE |
| K904901 | L11, L12 Linear and C11, C12 Convex Array TransducITX · Traditional | 03/26/1991SE |
| K884800 | Acta Genos ElectrocardiographDPS · Traditional | 06/22/1989SE |
| K864519 | Philips Computed Radiography System (PCR)LLZ · Traditional | 02/13/1987SE |
| K862416 | Fti 100 Medical Thermal ImagerLMC · Traditional | 07/01/1986SE |
| K862415 | Type 633 Computed Radiography (CR) FilmIWZ · Traditional | 07/01/1986SE |
| K853295 | Emodren Exchangeable Plastic BellowsGCY · Traditional | 08/20/1985SE |
| K853296 | Emodren Guide Needle for Drainage Tube & EmodrenBYY · Traditional | 08/15/1985SE |
| K851322 | Personal C3 3-CHANNEL ElectrocardiographDPS · Traditional | 05/16/1985SE |
Questions and answers
When was Fuji CR Imaging Plate cleared by the FDA?
Fuji CR Imaging Plate (K862414) received a 510(k) decision of Substantially Equivalent on February 26, 1987, 246 days after the submission was received.
What is the product code of K862414?
The FDA product code is EAM – Screen, Intensifying, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1960.