Canon X-Ray 35MM Cine Camera CSI-35
FDA 510(k) K853983 · Canon USA, Inc.
510(k) numberK853983
Submission
- Device name
- Canon X-Ray 35MM Cine Camera CSI-35
- Applicant
- Canon USA, Inc.
Jericho, NY, US - Received
- September 27, 1985
- Decision date
- October 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Canon X-Ray 35MM Cine Camera CSI-35 cleared by the FDA?
Canon X-Ray 35MM Cine Camera CSI-35 (K853983) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 19 days after the submission was received.
What is the product code of K853983?
The FDA product code is IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot, a Class II (moderate risk) device regulated under 21 CFR 892.1620.