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The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

Device Description

The Greatbatch Scientific MR Compatible Sinuscope is available in standard and autoclavable 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Greatbatch Scientific MR Compatible Sinuscope, based on the provided documents:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
MR Compatibility	Acceptable for use in a 1.5 Tesla static magnetic field	Found to be acceptable for use in a 1.5 Tesla static magnetic field. The device can be used in an MR or interventional MR environment not to exceed a 1.5 Tesla static magnetic field.
Magnetic Attraction	No observed string deflection	None
Magnetic Torque	No observed torque	None
Artifact	Not explicitly specified, but implied to be minimal	For T1 spin echo, artifact was the same size as the device (1). For FSPGR and T1 fast spin echo, artifact was slightly larger than the device (444 for FSPGR, ++ for T1 fast spin echo). The specific numeric values (e.g., 444) for artifact size are not fully explained but indicate a relatively small field of distortion. No absolute maximum artifact size is given.
RF Heating	Maximum temperature rise

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