Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

The Philips Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems are diagnostic magnetic resonance imaging devices that enable trained physicians to obtain cross-sectional images and spectroscopic data of the head, body, and extremities. The systems can be used for diagnostic imaging and to guide interventional and minimally invasive procedures, with image interpretation performed by trained physicians.

The principal technological components (magnet, transmit body coil, gradient coil, gradient amplifier, RF amplifier, and patient support) remain unchanged from the predicate device. Software updates in R13 introduce new features: SmartHeart (automated cardiac MRI planning using deep learning), CardiacQuant Perfusion (myocardial blood flow assessment), Cardiac Motion Correction, CINE FreeBreathing (free-breathing cine imaging), 4D MR-RT (free-breathing 3D imaging for radiotherapy planning), and IRIS (multi-shot diffusion imaging for higher resolution pelvic, prostate, and breast imaging).

Compliance demonstrated with IEC 60601-2-33 Edition 4.0 (MR equipment safety and performance), IEC 60601-1:2005 (general electrical safety), IEC 60601-1-2:2014 (electromagnetic disturbances), IEC 60601-1-6 Edition 3.2 (usability), IEC 60601-1-8:2006 (alarm systems), IEC 62304:2006 (software lifecycle), IEC 62366-1:2015 (usability engineering), and ISO 14971:2019 (risk management).

The subject device has the same indications for use, design principle, and fundamental technological components as the predicate device (K251397). Software enhancements offer alternative workflow planning and scanning methods without altering core imaging capability. Non-clinical verification and validation testing demonstrates compliance with international consensus standards, all risks are sufficiently mitigated, and the device meets acceptance criteria for its intended use, establishing substantial equivalence in terms of safety and effectiveness.