dS Wrist coil 8ch 1.5T
Philips Medical Systems Nederland B.V.The dS Wrist Coil 8ch 1.5T is a specialized MRI coil designed to produce high-quality diagnostic images of the wrist. It improves image clarity by using an 8-channel phased-array design for better signal reception, helping physicians accurately evaluate wrist conditions through MRI scans.
Intended Use
The dS Wrist Coil 8ch 1.5T is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanner to produce diagnostic images of the wrist that can be interpreted by a trained physician.
Technology
An 8-channel phased-array coil with rigid volume coils of 8 elements that closely encircle the wrist for high signal-to-noise ratio (SNR). The coil features a one-piece hinged design to facilitate patient set-up and includes a rigid base plate to reduce motion artifacts. Compatible with Philips Prodiva and MR5300 1.5T MR systems, utilizing energy from the MR scanner for imaging.
Performance
The device underwent extensive non-clinical testing including electrical and mechanical safety (IEC 60601-1), electromagnetic compatibility, image uniformity and signal-to-noise ratio testing (NEMA-MS standards), biological safety evaluation (ISO 10993-1), and cleaning validation (ISO 17664). Clinical testing involved board-certified radiologists reviewing image quality to confirm sufficiency for diagnostic use. These tests demonstrated safety and effective performance equivalent to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
21 days - 2
FDA Approval
10/18/2024
Other devices from Philips Medical Systems Nederland B.V.
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.