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FDA 510(k)

AIRO Computed Tomography (CT) X-ray System

K-Number: K160126 · 2016-04-19

ApplicantMobius Imaging
Decision Date2016-04-19
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. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K160126. 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 2016-04-19. The listed applicant is Mobius Imaging. The 510(k) number is K160126.

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 2016-04-19, under 510(k) number K160126.

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

The FDA 510(k) record lists Mobius Imaging 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.

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Other records listing Mobius Imaging 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.

K180393AIRO 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.

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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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