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The Fabius MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume.

The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less.

The Fabius MRI is a continuous flow anesthesia system usable in an MRI environment.

Fabius MRI is equipped with a compact breathing system, providing fresh gas decoupling, PEEP, and pressure limitation.

The following ventilation options are available:

• Volume Controlled Ventilation
• Pressure Controlled Ventilation
• Pressure Support (Optional)
• SIMV/PS (Optional)
• Manual Ventilation
• Spontaneous Breathing

Fabius MRI is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2),

The provided text is a 510(k) summary for the Fabius MRI device, an anesthesia gas machine. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance results, sample sizes for testing, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone performance studies.

Instead, the document focuses on:

• Device Identification: Applicant/Manufacturer name, contact, device name (Fabius MRI), common name (Gas-machine, anesthesia), classification details, and date of submission.
• Device Description: Fabius MRI is a continuous flow anesthesia system usable in MRI environments (1.5 and 3 Tesla magnets,

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