510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K131601Substantially Equivalent

Dell U3014 with Qubyx Perfectlum Bundle

Qubyx Limited, Nice, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131601 is the FDA 510(k) clearance record for DELL U3014 WITH QUBYX PERFECTLUM BUNDLE, a class II device, cleared for Qubyx Limited 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 3 510(k) clearances for Qubyx Limited, from to . As of , FDA records show no recalls naming K131601.

Clearance record

Decision date
Received
(399 days to decision)
Product code
PGY Display, Diagnostic Radiology
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Qubyx Limited 80, Rue Marechal Joffre, Nice, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGY

Trailing 12 months
5 clearances under product code PGY in the twelve months to October 2026, October 2026 the highest month at 2.
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 20262