6 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Intera 1.5T, Model Numbers: 781195 and 781295;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T, Model No. 781195
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Intera 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Intera 1.5T, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 2024
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195, 14) Intera 1.5T Pulsar New Model 781295, (Added 6/25/18) 15) Intera 1.5T Enterprise
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·April 25, 2018