Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

The Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 are 1.5T and 3.0T magnetic resonance diagnostic devices that enable trained physicians to obtain cross-sectional images of the head, body, or extremities for diagnostic purposes. They can also guide interventional and minimally invasive procedures using MR fluoroscopy, with image interpretation by trained physicians.

The subject devices introduce SmartSpeed Precise, a machine learning-based image reconstruction technique that increases signal-to-noise ratio (SNR), improves sharpness, and reduces ringing artifacts in MR images. SmartSpeed Precise combines denoisers from SmartSpeed AI and Precise Image features and replaces both for 2D Cartesian acquisition, but does not change the fundamental hardware components (magnet, transmit body coil, gradient coil, RF amplifier, patient support) compared to the predicate device.

IEC 60601-2-33 Ed. 3.2:2010 (MR safety and performance), ANSI/AAMI ES60601-1:2005 (general safety), IEC 60601-1-2:2014 (electromagnetic disturbances), IEC 60601-1-6 (usability), ANSI AAMI IEC 62304:2006 (software life cycle), ANSI AAMI IEC 62366-1:2015 (usability engineering), and ANSI AAMI ISO 14971:2019 (risk management).

The indications for use are identical to the predicate device, and SmartSpeed Precise does not change the device's intended purpose or introduce new safety concerns. Non-clinical verification and validation testing, including simulated use validation and reader evaluation by ABR-certified radiologists, demonstrated that SmartSpeed Precise produces images of equivalent or superior quality (better SNR and sharpness) compared to predicate reconstruction techniques while meeting all acceptance criteria. Risk management analysis confirmed no new risks are introduced and all residual risks remain acceptable.