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510(k) K203106

Nio Fusion 12MP (MDNC-12130) by Barco N.V. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2020
Date Received
October 15, 2020
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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