DEVICE: Clear Guide Optical Head (B201CGOH0)
Device Identifier (DI) Information
Clear Guide Optical Head
CGOH
In Commercial Distribution
CG-OH
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution
CG-OH
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
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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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)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, 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., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IYO | System, Imaging, Pulsed Echo, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K141806 | 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
b2ac64ea-265b-42c1-a591-e29a1b2e2573
September 18, 2023
5
September 21, 2016
September 18, 2023
5
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B201CGOH1 | 1 | B201CGOH0 | In Commercial Distribution |
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