dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
Philips Medical Systems Nederland B.V.The dS Breast and dS Sentinelle Breast coils are specialized attachments for MRI machines that help capture high-quality images of the breasts, chest wall, and axillary tissues. They help clinicians diagnose breast conditions and guide interventional procedures like biopsies. These coils are specifically shaped and optimized to improve image quality and patient comfort during breast MRI exams.
Intended Use
The Philips dS Breast and Sentinelle Breast coils are intended to be used in conjunction with compatible Philips 1.5T and 3.0T MRI systems in adult and adolescent patients to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. Some models also permit access for interventional procedures such as biopsy and localization.
Technology
These devices are specialized, receive-only phased array radiofrequency coils designed for use with Philips 1.5T and 3.0T MRI systems. They use multiple coil elements for improved image signal and support open designs to facilitate patient positioning and image quality for both diagnostic and interventional procedures.
Performance
Comprehensive non-clinical lab testing included measures such as image signal-to-noise ratio, image uniformity, acquired image quality, surface heating, decoupling circuit functionality, electrical and mechanical safety, and biocompatibility. All predefined acceptance criteria were met. Sample images were assessed by board-certified radiologists and deemed diagnostic quality. No clinical studies were required as indications for use and technology are equivalent to predicates.
Predicate Devices
No predicate devices specified
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