Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386
FDA 510(k) K060550 · Eastman Kodak Company
510(k) numberK060550
Submission
- Device name
- Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- March 2, 2006
- Decision date
- March 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
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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 |
| 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 |
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Questions and answers
When was Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386 cleared by the FDA?
Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386 (K060550) received a 510(k) decision of Substantially Equivalent on March 31, 2006, 29 days after the submission was received.
What is the product code of K060550?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.