Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AIRO Computed Tomography (CT) X-ray System

K-Number: K180393 · 2018-03-15

ApplicantMobius Imaging, LLC
Decision Date2018-03-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIRO Computed Tomography (CT) X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Mobius Imaging, LLC. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K180393. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRO Computed Tomography (CT) X-ray System?

AIRO Computed Tomography (CT) X-ray System is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Mobius Imaging, LLC. The 510(k) number is K180393.

When did AIRO Computed Tomography (CT) X-ray System receive FDA 510(k) clearance?

AIRO Computed Tomography (CT) X-ray System received FDA 510(k) clearance on 2018-03-15, under 510(k) number K180393.

Who is the listed applicant for AIRO Computed Tomography (CT) X-ray System?

The FDA 510(k) record lists Mobius Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRO Computed Tomography (CT) X-ray System?

The FDA product code for AIRO Computed Tomography (CT) X-ray System is JAK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT01399385New Heart Imaging Techniques to Evaluate Possible Heart DiseaseRECRUITINGNCT01955018Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related ConditionsCOMPLETEDNCT02907866Use of Endobronchial Ultrasound Scope (EBUS) Transducer to Identify Pneumothorax-A Feasibility StudyTERMINATEDNCT03621306DXA Study of Precision and ReliabilityRECRUITINGNCT07092553Evaluation of C-arm PCD-CBCT for Image-Guided InterventionsNOT_YET_RECRUITINGNCT07516145Robotic Transjugular Transcatheter Tricuspid Valve ReplacementRECRUITING

Other records listing Mobius Imaging, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160126AIRO Computed Tomography (CT) X-ray System

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑