FDA.reportPublic FDA data

Clear Guide Optical Head

Primary DI
B201CGOHM0
Brand
Clear Guide Optical Head
Company
CLEAR GUIDE MEDICAL, INC.
Model
CGOHM
Catalog number
CG-OH-M
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.
Published
2022-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141806000
K201898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141806000CLEAR GUIDE ONEClear Guide Medical2014-09-19IYO
K201898000Clear Guide SCENERGYClear Guide Medical2020-07-31JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B201CGOHM1PackageHIBCC1In Commercial Distribution
B201CGOHM0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological video camera patient positioning/tracking system cameraA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1 (443) 267-7661support@clearguidemedical.com

Regulatory Flags#

DUNS number
965399905
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B201CGOH0Clear Guide Optical HeadCGOHCG-OH2016-09-21
B201CGTT0Clear Guide TipTAGCGTT2017-04-07
B201CGVM0Clear Guide VisiMARKERCGVM2016-09-21
B201CGCORE170Clear Guide CORECGCORE17CG-CORE172022-10-07
B201CGCORE240Clear Guide CORECGCORE24CG-CORE242022-10-07
B201CGCORE130Clear Guide CORECGCORE13CG-CORE-132022-10-06
B201CGCORE24MR0Clear Guide CORECGCORE24MRCG-CORE24-MR2022-10-06
B201CGVM20Clear Guide VisiMARKER IICGVM2CG-VM22022-10-04
B201CGVM2NS0Clear Guide VisiMARKER II Non-SterileCGVM2NSCG-VM2-NS2022-10-04
B201CGVMNS0Clear Guide VisiMARKER Non-SterileCGVMNSCG-VM-NS2022-10-04
B201CGSG140Clear Guide SteriGRIDCGSG14CG-SG142026-05-11
B201CGSG0Clear Guide SteriGRIDCGSGCG-SG2025-01-10
B201CGPAT0Clear Guide TP Access ToolCGPATCG-PAT2025-01-10
B201CGSCENERGYTP0Clear Guide SCENERGY TPCGSCENERGYTPCG-SCENERGY-TP2025-01-10
B201CGTPF0Clear Guide TP Access FrameCGTPFCG-TPF2025-01-10
B201CGTPP0Clear Guide TP Access PostsCGTPPCG-TPP2025-01-10
B201CGSMM0Clear Guide SteriMASKCGSMMCG-SM-M2022-10-03
B201CGSCENERGY0Clear Guide SCENERGYCGSCENERGY2016-09-21
B201CGSM0Clear Guide SteriMASKCGSM2016-09-21
B201CGONE0Clear Guide ONECGONE2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29
00850025268219Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2023-10-13
00850025268202Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2023-09-11
00841436102797eTRAX™ Needle System Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2023-05-08
00850025268165Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2022-12-14