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510(k) K150821

MDNG-3220 (Nio 3MP LED) by Barco — Product Code PGY

K150821 is an FDA 510(k) premarket notification submitted by Barco for the device "MDNG-3220 (Nio 3MP LED)". The FDA issued a decision of Substantially Equivalent on April 10, 2015. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2015
Date Received
March 27, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

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FDA data resources