Cleared Traditional

K231420 - Aura 10 PET/CT (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231420 · Xeos Medical · Radiology device
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Aug 2023
Decision
86d
Days
Class 2
Risk

K231420 is an FDA 510(k) clearance for the Aura 10 PET/CT. Classified as Cabinet, Emission Computed Tomography System (product code QXL), Class II - Special Controls.

Submitted by Xeos Medical (Gent, BE). The FDA issued a Cleared decision on August 10, 2023 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K231420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2023
Decision Date August 10, 2023
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QXL Cabinet, Emission Computed Tomography System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
Definition 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 During Surgical Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.