5 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
FDA Enforcement
Class II
·Ongoing·Philips North America·February 7, 2024
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
FDA Enforcement
Class II
·Ongoing·Philips North America·June 18, 2025
Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 2024
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·April 25, 2018