13 results
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36ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·April 25, 2018
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·September 6, 2017
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·November 18, 2015
The GC80 Digital X-ray Imaging System
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·March 14, 2018
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·June 5, 2019
WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·August 21, 2019
HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·August 21, 2019
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·August 19, 2020
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
FDA Enforcement
Class II
·Ongoing·NeuroLogica Corporation·April 26, 2023
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
FDA Enforcement
Class II
·Ongoing·NeuroLogica Corporation·July 12, 2023
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
FDA Enforcement
Class II
·Ongoing·NeuroLogica Corporation·February 21, 2024
GM60A. Digital Diagnostic Mobile X-Ray System.
FDA Enforcement
Class II
·Ongoing·NeuroLogica Corporation·August 28, 2024
GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
FDA Enforcement
Class II
·Ongoing·NeuroLogica Corporation·November 19, 2025