Cleared Traditional

K180393 - AIRO Computed Tomography (CT) X-ray System

K180393 is the FDA 510(k) clearance for AIRO Computed Tomography (CT) X-ray System by Mobius Imaging, LLC. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K180393 · Mobius Imaging, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
30d
Days
Class 2
Risk

K180393 is an FDA 510(k) clearance for the AIRO Computed Tomography (CT) X-ray System. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Mobius Imaging, LLC (Shirley, US). The FDA issued a Cleared decision on March 15, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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.

View all Mobius Imaging, LLC devices

Submission Details

510(k) Number K180393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2018
Decision Date March 15, 2018
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 586
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K180393.
syngo.CT Coronary Analysis
K173637 · Siemens Medical Solutions USA, Inc. · Mar 2018
SOMATOM Edge Plus
K173607 · Siemens Medical Solutions USA, Inc. · Mar 2018
Philips Incisive CT
K180015 · Philips Healthcare (Suzhou) Co., Ltd. · Mar 2018
syngo.CT Clinical Extensions
K173625 · Siemens Medical Solutions USA, Inc. · Mar 2018
uCT Computed Tomography X-ray System
K172135 · Shanghai United Imaging Healthcare Co., Ltd. · Mar 2018
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
K173468 · Toshibamedical Systems Corporation · Feb 2018