Clear Guide Optical Head

Basic Information

• Brand Name: Clear Guide Optical Head
• Primary DI: B201CGOHM0
• Version / Model: CGOHM
• Catalog Number: CG-OH-M
• Company Name: CLEAR GUIDE MEDICAL, INC.
• Labeler DUNS: 965399905
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-07
• Public Version: 3
• Public Version Date: 2025-04-04
• Public Version Status: Update
• Public Device Record Key: 9c221568-fe48-4be1-9eb0-a3f9a040058f

Device Description

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B201CGOHM0	HIBCC
Package	B201CGOHM1	HIBCC	Box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141806	000
K201898	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal