Jpi Intensifying Screen
FDA 510(k) K954161 · Jpi Healthcare Co, Ltd.
510(k) numberK954161
Submission
- Device name
- Jpi Intensifying Screen
- Applicant
- Jpi Healthcare Co, Ltd.
Bayside, NY, US - Received
- September 5, 1995
- Decision date
- February 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K942399 | Kyokko Um Series Intensifying ScreenEAM · Traditional | Fujifilm Medical System U.S.A., Inc. | 06/10/1994SE |
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| K142930 | Exam Vue DRKPR · Traditional | 04/17/2015SE |
| K102327 | Clearvision DR 7000FMQB · Traditional | 04/13/2012SE |
| K101779 | Clearvision DR 2000 Digital Radiography X-Ray SystemKPR · Traditional | 05/16/2011SE |
| K955706 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 02/12/1996SE |
| K950043 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 05/10/1995SE |
Questions and answers
When was Jpi Intensifying Screen cleared by the FDA?
Jpi Intensifying Screen (K954161) received a 510(k) decision of Substantially Equivalent on February 2, 1996, 150 days after the submission was received.
What is the product code of K954161?
The FDA product code is EAM – Screen, Intensifying, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1960.