Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems

Philips Magnetic Resonance (MR) systems are diagnostic imaging devices that enable trained physicians to obtain cross-sectional images, spectroscopic images, and spectra of the internal structure of the head, body, or extremities. These 1.5T and 3.0T MR systems with 60cm and 70cm bores can be used for diagnostic imaging and to guide interventional and minimally invasive procedures when used with appropriate MR Conditional or MR Safe instrumentation.

The subject devices have the same fundamental MR technology as the predicate devices (magnet, transmit body coil, gradient coil, gradient amplifier, RF amplifier, and patient support). Three software changes are introduced: (1) early detection of severe gradient malfunctions that locks the system if detected, (2) smoke detector software support extended from Ingenia Elition S/X to all 70cm bore systems, and (3) SENSE XL Torso Coil workflow extensions with temperature monitoring and operator guidance.

IEC 60601-1-6 Edition 3.2 (usability), ANSI AAMI IEC 62304:2006/A1:2016 (software life cycle), ANSI AAMI IEC 62366-1:2015+AMD1:2020 (usability engineering), ANSI AAMI ISO 14971:2019 (risk management), ISO 15223-1:2021 (medical device symbols), and ISO 20417:2021 (manufacturer-supplied information).

The subject devices maintain identical indications for use and fundamental technological design features as the predicate devices. The three software changes are equivalent safety and effectiveness improvements rather than fundamental alterations: the gradient malfunction detection is an additional protective layer without changing intended use, smoke detector extension uses the same technology across different bore sizes, and the SENSE XL Torso Coil temperature monitoring is operator guidance that does not alter diagnostic capability. Non-clinical testing demonstrates compliance with recognized consensus standards, and risk management shows all risks are sufficiently mitigated with no new risks introduced.