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510(k) K151505

Coronis Uniti by Barco N.V. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2015
Date Received
June 4, 2015
Clearance Type
Traditional
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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Other clearances for product code PGY

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  • K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W (October 25, 2024)
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