16 results
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26ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Recall
Terminated
·NeuroLogica Corporation·Product code IZL·May 6, 2019
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
FDA Recall
Terminated
·NeuroLogica Corporation·Product code IZI·September 14, 2015
The GC80 Digital X-ray Imaging System
FDA Recall
Terminated
·NeuroLogica Corporation·Product code KPR·June 22, 2017
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 Recall
Terminated
·NeuroLogica Corporation·Product code KPR·May 24, 2017
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 Recall
Terminated
·NeuroLogica Corporation·Product code IYN·July 25, 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 Recall
Terminated
·NeuroLogica Corporation·Product code IYN·July 25, 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 Recall
Terminated
·NeuroLogica Corporation·Product code JAK·July 15, 2020
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
FDA Recall
Terminated
·NeuroLogica Corporation·Product code MQB·January 12, 2018
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