510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151505Substantially Equivalent

Coronis Uniti

Barco N.V., Kortrijk, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K151505 is the FDA 510(k) clearance record for Coronis Uniti, a class II device, cleared for Barco N.V. on under FDA product code PGY (Display, Diagnostic Radiology). FDA's definition for product code PGY reads: "The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners". FDA records list 53 510(k) clearances for Barco N.V., from to . As of , FDA records show no recalls naming K151505.

Clearance record

Decision date
Received
(43 days to decision)
Product code
PGY Display, Diagnostic Radiology
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Barco N.V. President Kennedypark 35, Kortrijk, BE
510(k) summary
Statement
Third party review
No

Clearances, product code PGY

Trailing 12 months
3 clearances under product code PGY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PGY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260