Trans X-1000
FDA 510(k) K945635 · Canon USA, Inc.
510(k) numberK945635
Submission
- Device name
- Trans X-1000
- Applicant
- Canon USA, Inc.
Lake Success, NY, US - Received
- November 16, 1994
- Decision date
- February 1, 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 Trans X-1000 cleared by the FDA?
Trans X-1000 (K945635) received a 510(k) decision of Substantially Equivalent on February 1, 1995, 77 days after the submission was received.
What is the product code of K945635?
The FDA product code is KPX – Changer, Radiographic Film/Cassette, a Class II (moderate risk) device regulated under 21 CFR 892.1860.