Kodak Eclipse Image Processing Software
FDA 510(k) K060137 · Eastman Kodak Company
510(k) numberK060137
Submission
- Device name
- Kodak Eclipse Image Processing Software
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- January 19, 2006
- Decision date
- March 16, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
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| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
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| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
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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 |
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| K040378 | Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253IXA · Traditional | 05/24/2004SE |
| K040556 | Trophypan C with Orthoimaging/Omsimaging AccessoryEHD · Special | 04/07/2004SE |
Questions and answers
When was Kodak Eclipse Image Processing Software cleared by the FDA?
Kodak Eclipse Image Processing Software (K060137) received a 510(k) decision of Substantially Equivalent on March 16, 2006, 56 days after the submission was received.
What is the product code of K060137?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.