9 results
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22ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 2, 2024
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
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. Model (REF) Numbers 781270, 782113, 782129.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 2024
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025