Cleared Traditional

K131431 - AIRO CT SYSTEM

K131431 is an FDA 510(k) clearance for AIRO CT SYSTEM, manufactured by Mobius Imaging, LLC. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K131431 · Mobius Imaging, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
132d
Days
Class 2
Risk

K131431 is an FDA 510(k) clearance for the AIRO CT SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Mobius Imaging, LLC (Ayer, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mobius Imaging, LLC devices

FDA 510(k) Submission Details - K131431

510(k) Number K131431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date September 26, 2013
Days to Decision 132 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
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 727
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K131431.
SOMATOM DEFINITION AS OPEN
K130901 · Siemens Medical Systems, Inc. · Jan 2014
MYOPERFUSION
K132523 · Toshibamedical Systems Corporation · Dec 2013
AQUILION ONE VISION, V6.0
K132222 · Toshibamedical Systems Corporation · Nov 2013
BRILLIANCE ICT
K131773 · Philips Healthcare (Cleveland) · Sep 2013
OPTIMA CT660
K131576 · Ge Medical Systems, LLC · Aug 2013
SYNGO CT PULMO 3D
K123540 · Siemens Medical Systems, Inc. · Aug 2013