cortiQ PRO

Primary DI
EBCI80600
Brand
cortiQ PRO
Company
g.tec medical engineering GmbH
Model
TD 1.x
Device description
cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
Published
2020-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal
OLTNon-Normalizing Quantitative Electroencephalograph Software
OLUNormalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OLUNormalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191432000cortiQ PROG.Tec Medical Engineering GmbH2020-01-24OLU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBCI80600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Contacts#

Phone, Email table
PhoneEmail
+437251222400support@gtec.at

Regulatory Flags#

DUNS number
300916041
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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EBCI5700PRO0g.Nautilus PRO32 FLEXIBLE channels5700PRO2021-04-16
EBCI5710PRO0g.Nautilus PRO16 FLEXIBLE channels5710PRO2021-04-16
EBCI5720PRO0g.Nautilus PRO8 FLEXIBLE channels5720PRO2021-04-16
EBCI11500g.Estim PRO111502018-05-30
EBCI5100PRO0g.Nautilus PRO32-Channel5100PRO2017-11-23
EBCI5101PRO0g.Nautilus PRO32-Channel-CSP5101PRO2017-11-23
EBCI5110PRO0g.Nautilus PRO16-Channel5110PRO2017-11-23
EBCI5111PRO0g.Nautilus PRO16-Channel-mB5111PRO2017-11-23
EBCI5112PRO0g.Nautilus PRO16-Channel-rX5112PRO2017-11-23
EBCI5120PRO0g.Nautilus PRO8-Channel5120PRO2017-11-23
EBCI5200PRO0g.Nautilus PRO32-Channel Sahara5200PRO2017-11-23
EBCI5201PRO0g.Nautilus PRO32-Channel-CSP Sahara5201PRO2017-11-23
EBCI5210PRO0g.Nautilus PRO16-Channel Sahara5210PRO2017-11-23
EBCI5211PRO0g.Nautilus PRO16-Channel-mB Sahara5211PRO2017-11-23
EBCI5212PRO0g.Nautilus PRO16-Channel-rX Sahara5212PRO2017-11-23
EBCI5220PRO0g.Nautilus PRO8-Channel Sahara5220PRO2017-11-23
EBCI7001US0g.HIamp80-Channel Amplifier70012017-11-23
EBCI7002US0g.HIamp144-Channel Amplifier70022017-11-23

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