Nio 2MP (MDNG-2121)

FDA 510(k) K091172 · Barco N.V.

Substantially Equivalent

510(k) numberK091172

Submission

Device name
Nio 2MP (MDNG-2121)
Applicant
Barco N.V.
8500 Kortrijk, BE
Received
April 22, 2009
Decision date
May 5, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

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 Nio 2MP (MDNG-2121) cleared by the FDA?

Nio 2MP (MDNG-2121) (K091172) received a 510(k) decision of Substantially Equivalent on May 5, 2009, 13 days after the submission was received.

What is the product code of K091172?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.