Kyokko Green Series Intensifying Screens
FDA 510(k) K942235 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK942235
Submission
- Device name
- Kyokko Green Series Intensifying Screens
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Stamford, CT, US - Received
- May 9, 1994
- Decision date
- August 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K942399 | Kyokko Um Series Intensifying ScreenEAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 06/10/1994SE |
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Questions and answers
When was Kyokko Green Series Intensifying Screens cleared by the FDA?
Kyokko Green Series Intensifying Screens (K942235) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 100 days after the submission was received.
What is the product code of K942235?
The FDA product code is EAM – Screen, Intensifying, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1960.