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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 a medical device manufactured by Mobius Imaging, LLC. It received FDA 510(k) clearance on 2018-03-15 under approval 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. It is manufactured by Mobius Imaging, LLC. The 510(k) number is K180393.

When was AIRO Computed Tomography (CT) X-ray System approved by the FDA?

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

What company makes AIRO Computed Tomography (CT) X-ray System?

AIRO Computed Tomography (CT) X-ray System is manufactured by Mobius Imaging, LLC.

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.

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Related PubMed Literature

PMID: 42086270 Abdominopelvic computed tomography during pregnancy and the risk of congenital malformations: protocol for a nationwide population-based cohort study in South Korea. BMJ open (2026) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025)

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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.

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