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FDA 510(k)

AIRO CT SYSTEM

K-Number: K131431 · 2013-09-26

ApplicantMobius Imaging, LLC
Decision Date2013-09-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIRO CT 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 2013-09-26 under 510(k) number K131431. 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 CT SYSTEM?

AIRO CT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Mobius Imaging, LLC. The 510(k) number is K131431.

When did AIRO CT SYSTEM receive FDA 510(k) clearance?

AIRO CT SYSTEM received FDA 510(k) clearance on 2013-09-26, under 510(k) number K131431.

Who is the listed applicant for AIRO CT 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 CT SYSTEM?

The FDA product code for AIRO CT SYSTEM is JAK.

Related Clinical Trials

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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.

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Official Source

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

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