Cornis 5MP Medical Flat Panel Display System
FDA 510(k) K023341 · Barco N.V.
510(k) numberK023341
Submission
- Device name
- Cornis 5MP Medical Flat Panel Display System
- Applicant
- Barco N.V.
La Jolla, CA, US - Received
- October 7, 2002
- Decision date
- December 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cornis 5MP Medical Flat Panel Display System cleared by the FDA?
Cornis 5MP Medical Flat Panel Display System (K023341) received a 510(k) decision of Substantially Equivalent on December 23, 2002, 77 days after the submission was received.
What is the product code of K023341?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.