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510(k) Data Aggregation
K Number
K180393Device Name
AIRO Computed Tomography (CT) X-ray System
Manufacturer
Date Cleared
2018-03-15
(30 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Mobius Imaging, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding patients weighing over 400 lbs (182 kg).
Device Description
The Mobius Airo is a Mobile Intraoperative Computed Tomography (CT) System. The Airo has a large-diameter bore designed for intraoperative use; the main features include a 107cm bore, with a 51.2cm field of view (FOV). The Airo has two modes of operation; transport and scanning (both helical and axial). In its scanning mode, translation along the longitudinal axis is achieved through movement of the gantry along the length of the system base (rather than through movement of the patient support table).
The lightweight translating gantry consists of a rotating disk with a solid-state X-ray generator, solid state detector array (that includes detector modules that consist of Gadolinium Oxysulfide (GOS) and Photodiode Array). Each detector module includes a 32 x 16-pixel scintillator array that produces scintillation events responsive to irradiation by X-rays. The Airo also includes a collimator, control computer, communications link, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and a DC brushless servo drive system (translation).
The power system consists of batteries which provide system power while unplugged from a standard power outlet (e.g., during transport of the System and also during scanning). The base has retractable rotating caster wheels and electrical drive system can be easily moved to different locations.
In addition, the System has the necessary safety features such as emergency stop button, X-ray indicators, interlocks, patient alignment lasers, and 110 percent X-ray timer. The software helical and axial reconstruction algorithms are both based on an exact filtered-back projection.
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K Number
K131431Device Name
AIRO CT SYSTEM
Manufacturer
Date Cleared
2013-09-26
(132 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
MOBIUS IMAGING, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AIRO™ is intended to be used for non-contrast X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients weighing over 400 lbs (182 kg).
Airo is contraindicated as the principal means of guidance during surgical procedures. The physician must verify navigation accuracy using known anatomical landmarks or an equivalent verification method when used in surgical procedures.
Device Description
The Mobius Airo is a mobile high resolution Computed Tomography (CT) System similar to the NL4000 BodyTom CT System. The Airo has a large-diameter bore designed for intra-operative use; the main features include a 107cm bore, with a 51.2cm field of view (FOV). The Airo has two modes of operation; transport and scanning mode, translation along the longitudinal axis is achieved through movement of the gantry along the length of the system base (rather than through movement of the patient support table).
The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array (that includes detector modules that consist of a layered Cadmium Tungstate (CdWO4) and Photodiode Array). Each detector module includes a 32 x 16 pixel scintillator array that produces scintillation events responsive to irradiation by X-rays. The Airo also includes a collimator, control computer, communications link, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation), and a DC brushless servo drive system (translation).
The power system consists of batteries which provide system power while unplugged from a standard power outlet (e.g., during transport of the System and also during scanning). The base has retractable rotating caster wheels and electrical drive system can be easily moved to different locations.
In addition, the System has the necessary safety features such as emergency stop button, X-ray indicators, interlocks, patient alignment lasers, and 110 percent X-ray timer. The software helical reconstruction is based on an exact filtered-back projection algorithm.
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Ask a specific question about this device
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