2 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 29, 2024