510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K173381Substantially Equivalent

Nexxis OR

Barco N.V., Kortrijk, BE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173381 is the FDA 510(k) clearance record for Nexxis OR, a class II device, cleared for Barco N.V. on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 53 510(k) clearances for Barco N.V., from to . As of , FDA records show 3 recalls naming K173381.

Clearance record

Decision date
Received
(115 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Barco N.V. Beneluxpark 21, Kortrijk, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXJ

Trailing 12 months

FDA records hold no clearances under product code DXJ in the trailing twelve months.

FDA records show no clearances under product code DXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260