Fluoricon 500 Image Intensifiers
FDA 510(k) K770094 · General Electric Co.
510(k) numberK770094
Submission
- Device name
- Fluoricon 500 Image Intensifiers
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- January 17, 1977
- Decision date
- January 21, 1977
- 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 |
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| K103489 | GE Veo Reconstruction OptionJAK · Traditional | 09/09/2011SE |
| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was Fluoricon 500 Image Intensifiers cleared by the FDA?
Fluoricon 500 Image Intensifiers (K770094) received a 510(k) decision of Substantially Equivalent on January 21, 1977, 4 days after the submission was received.
What is the product code of K770094?
The FDA product code is EAM – Screen, Intensifying, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1960.