Fuji Medical Laser Imager
FDA 510(k) K900885 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK900885
Submission
- Device name
- Fuji Medical Laser Imager
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Stamford, CT, US - Received
- February 26, 1990
- Decision date
- March 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Fuji Medical Laser Imager cleared by the FDA?
Fuji Medical Laser Imager (K900885) received a 510(k) decision of Substantially Equivalent on March 23, 1990, 25 days after the submission was received.
What is the product code of K900885?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.