Kodak Pacs
FDA 510(k) K060055 · Eastman Kodak Company
510(k) numberK060055
Submission
- Device name
- Kodak Pacs
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- January 9, 2006
- Decision date
- February 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Kodak Pacs cleared by the FDA?
Kodak Pacs (K060055) received a 510(k) decision of Substantially Equivalent on February 7, 2006, 29 days after the submission was received.
What is the product code of K060055?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.