DEVICE: Clear Guide Optical Head (B201CGOHM0)
Device Identifier (DI) Information
Clear Guide Optical Head
CGOHM
In Commercial Distribution
CG-OH-M
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution
CG-OH-M
CLEAR GUIDE MEDICAL, INC.
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
47849 | Radiological video camera patient positioning/tracking system camera |
A dedicated camera designed as a component of a video camera patient positioning/tracking system to provide synchronized continuous image capture and illumination of the patient. It is typically mounted strategically in pairs or more within the treatment room to focus and zoom on the patient to aid in the correct positioning of the patient and track events during a diagnostic imaging, treatment planning or radiation therapy procedure, including automated beam-hold and respiratory gated imaging. It is used together with an assembly of hardware/software devices to image and reconstruct three-dimensional (3-D) surfaces of a patient.
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Active | false |
62782 | Optical surgical navigation device tracking system |
A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)]; it may be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ENT, neurosurgery, CMF surgery].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
JAK | System, X-Ray, Tomography, Computed |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141806 | 000 |
K201898 | 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
9c221568-fe48-4be1-9eb0-a3f9a040058f
April 04, 2025
3
October 07, 2022
April 04, 2025
3
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 |
---|---|---|---|---|---|
B201CGOHM1 | 1 | B201CGOHM0 | 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