dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T

The Philips Neurovascular MR Coil is a family of magnetic resonance receiver coils (dS Base, dS Head, and dS HeadNeck variants at 1.5T and 3.0T field strengths) designed to work with Philips MRI scanners. These lightweight, multi-channel phased-array coils are used to receive MR signals and produce diagnostic images of head, neck, brain, spine, and vascular anatomy for interpretation by trained physicians.

The principal technological components—PCBs, system cables, baluns, and positioning pads—are unchanged from the predicate device. The key difference is the housing material: dS Base coils changed from polyester (Trirex) to polycarbonate (Lexan 925), while dS Head and dS HeadNeck coils changed from polyester (Trirex) to copolyester (MFX-421). All coils maintain the same signal reception and amplification principle based on hydrogen nuclear resonance.

Testing verified compliance with IEC 60601-2-33 (MR equipment safety), IEC 60601-1-2 (electromagnetic disturbances), ISO 10993 series (biocompatibility), ANSI/AAMI ES60601-1 (electrical safety), ISO 14971 (risk management), and ISO 15223 (device symbols). Packaging compliance was tested per ISTA 3A 2018.

Substantial equivalence is established because the subject devices have the same intended use, design features, and fundamental MR signal reception technology as the predicate device K123492. Non-clinical verification and validation testing demonstrates all acceptance criteria are met. The housing material changes present no new safety or effectiveness risks, and risk management shows all residual risks remain acceptable. No clinical testing was required because indications for use remain similar and no novel technological characteristics warrant clinical data.