DEVICE: Clear Guide CORE (B201CGCORE240)
Device Identifier (DI) Information
Clear Guide CORE
CGCORE24
In Commercial Distribution
CG-CORE24
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution
CG-CORE24
CLEAR GUIDE MEDICAL, INC.
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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40936 | Ultrasound imaging system workstation |
A freestanding image processing workstation specifically designed to be networked with one or more diagnostic ultrasound imaging systems. It is sometimes considered to be a component to a picture archiving and communication system (PACS). An ultrasound workstation differs from the operator's console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more ultrasounds.
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Active | false |
45195 | Stereotactic surgery system workstation |
A freestanding image processing device specifically designed to be networked with one or more stereotactic surgery systems. It typically does not contain the controls for the direct operation of the system, but rather is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the stereotactic system's operator console. It may be configured to provide the capability to further process, manipulate and/or view patient images and information collected from one or more systems.
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Active | false |
61409 | Optical surgical navigation device tracking system workstation, mobile |
A mains electricity (AC-powered) component of an optical surgical navigation device tracking system intended to act as the user interface for controlling the function of the system during computer assisted surgery (CAS). It consists of a mobile (on wheels) computer unit with an image display screen, a mobile infrared (IR) light camera, and integrated software; it may be a stand-alone unit or integrated into an endoscopic video tower or surgical pendant. The system provides an optical tool for the tracking of instruments and patient with respect to pre-acquired images (e.g., CT or MRI scan), or real-time image data [e.g., ultrasound (US) data].
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Active | false |
64248 | Panel computer |
A non-dedicated, electrically-powered, compact computer unit with an integrated touchscreen monitor designed to be used in a mobile platform (e.g., mounted on a stand, mount, pole, laboratory equipment). It is typically made of or coated with an antimicrobial material to prevent cross-contamination in a medical setting.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JAK | System, X-Ray, Tomography, Computed |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K153004 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a0698437-57ee-47ad-84e8-4dba67b2db7d
October 17, 2022
1
October 07, 2022
October 17, 2022
1
October 07, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B201CGCORE241 | 1 | B201CGCORE240 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 (443) 267-7661
support@clearguidemedical.com
support@clearguidemedical.com