Cornis 5MP Medical Flat Panel Display System

FDA 510(k) K023341 · Barco N.V.

Substantially Equivalent

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

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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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.