Kodak Insight Twin-Load Insert
FDA 510(k) K942909 · Eastman Kodak Company
510(k) numberK942909
Submission
- Device name
- Kodak Insight Twin-Load Insert
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- June 21, 1994
- Decision date
- July 29, 1994
- 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 |
| 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 |
| 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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| K060137 | Kodak Eclipse Image Processing SoftwareMQB · Special | 03/16/2006SE |
| K060079 | Kodak Model CR-7400 Digital Radiography SystemMUH · Special | 02/08/2006SE |
| K060055 | Kodak PacsLLZ · Traditional | 02/07/2006SE |
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| K051483 | Kodak Directview DR System DetectorMQB · Traditional | 06/21/2005SE |
| K051258 | Kodak Directview DR 7500 System, Model 8791345KPR · Special | 06/01/2005SE |
| K042159 | Kodak Color Medical Imager 1000LMC · Traditional | 09/24/2004SE |
| K042158 | Kodak Medical Imager 300LMC · Traditional | 09/24/2004SE |
| K040378 | Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253IXA · Traditional | 05/24/2004SE |
Questions and answers
When was Kodak Insight Twin-Load Insert cleared by the FDA?
Kodak Insight Twin-Load Insert (K942909) received a 510(k) decision of Substantially Equivalent on July 29, 1994, 38 days after the submission was received.
What is the product code of K942909?
The FDA product code is EAM – Screen, Intensifying, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1960.