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 a medical device manufactured by Mobius Imaging. It received FDA 510(k) clearance on 2016-04-19 under approval 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. It is manufactured by Mobius Imaging. The 510(k) number is K160126.
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 2016-04-19, under approval number K160126.
What company makes AIRO Computed Tomography (CT) X-ray System?
AIRO Computed Tomography (CT) X-ray System is manufactured by Mobius Imaging.
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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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.