Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600
FDA 510(k) K983905 · Eastman Kodak Company
510(k) numberK983905
Submission
- Device name
- Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- November 3, 1998
- Decision date
- January 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600 cleared by the FDA?
Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600 (K983905) received a 510(k) decision of Substantially Equivalent on January 25, 1999, 83 days after the submission was received.
What is the product code of K983905?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.