Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film Imager
FDA 510(k) K060440 · Codonics, Inc.
510(k) numberK060440
Submission
- Device name
- Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film Imager
- Applicant
- Codonics, Inc.
Middleburg Heights, OH, US - Received
- February 21, 2006
- Decision date
- March 16, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film Imager cleared by the FDA?
Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film Imager (K060440) received a 510(k) decision of Substantially Equivalent on March 16, 2006, 23 days after the submission was received.
What is the product code of K060440?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.