Kodak Ektascan Triad Laser Printer System, Photon Laser Printer
FDA 510(k) K951807 · Kodak Health Imaging Systems, Inc.
510(k) numberK951807
Submission
- Device name
- Kodak Ektascan Triad Laser Printer System, Photon Laser Printer
- Applicant
- Kodak Health Imaging Systems, Inc.
Dallas, TX, US - Received
- April 19, 1995
- Decision date
- September 13, 1995
- 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 Ektascan Triad Laser Printer System, Photon Laser Printer cleared by the FDA?
Kodak Ektascan Triad Laser Printer System, Photon Laser Printer (K951807) received a 510(k) decision of Substantially Equivalent on September 13, 1995, 147 days after the submission was received.
What is the product code of K951807?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.