510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231420Substantially Equivalent

Aura 10 PET/CT

Xeos Medical, Gent, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231420 is the FDA 510(k) clearance record for Aura 10 PET/CT, a class II device, cleared for Xeos Medical on under FDA product code QXL (Cabinet, Emission Computed Tomography System). FDA's definition for product code QXL reads: "Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised...". FDA records list one 510(k) clearance for Xeos Medical. As of , FDA records show no recalls naming K231420.

Clearance record

Decision date
Received
(86 days to decision)
Product code
QXL Cabinet, Emission Computed Tomography System
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Xeos Medical Ottergemsesteenweg-Zuid 808, Gent, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXL

Trailing 12 months

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

FDA records show no clearances under product code QXL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXL, 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