DEVICE: Clear Guide CORE (B201CGCORE130)

Device Identifier (DI) Information

Clear Guide CORE
CGCORE13
In Commercial Distribution
CG-CORE-13
CLEAR GUIDE MEDICAL, INC.
B201CGCORE130
HIBCC

1
965399905 *Terms of Use
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-CORE13 model is a tablet PC with a 13" screen.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

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?
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.
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.
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].
Active false
38453 Portable computer
A portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard and/or touchscreen integrated into one unit in the form of a laptop, tablet, palmtop or other hand-held (including smartphone) device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JAK System, X-Ray, Tomography, Computed
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K201898 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6ae869dc-5a4a-43ae-9eb4-78b22c031706
October 25, 2022
2
October 06, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B201CGCORE131 1 B201CGCORE130 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1 (443) 267-7661
support@clearguidemedical.com
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