FDA.reportPublic FDA data

Clear Guide ONE

Primary DI
B201CGONE1
Brand
Clear Guide ONE
Company
CLEAR GUIDE MEDICAL, INC.
Model
CGONE
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141806000CLEAR GUIDE ONEClear Guide Medical2014-09-19IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B201CGONE1PackageHIBCC1In Commercial Distribution
B201CGONE0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

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
B201CGSG140Clear Guide SteriGRIDCGSG14CG-SG142026-05-11
B201CGTT0Clear Guide TipTAGCGTT2017-04-07
B201CGVM0Clear Guide VisiMARKERCGVM2016-09-21
B201CGSG0Clear Guide SteriGRIDCGSGCG-SG2025-01-10
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
B201CGOH0Clear Guide Optical HeadCGOHCG-OH2016-09-21
B201CGOHM0Clear Guide Optical HeadCGOHMCG-OH-M2022-10-07
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
B201CGCORE130Clear Guide CORECGCORE13CG-CORE-132022-10-06
B201CGCORE170Clear Guide CORECGCORE17CG-CORE172022-10-07
B201CGCORE240Clear Guide CORECGCORE24CG-CORE242022-10-07
B201CGCORE24MR0Clear Guide CORECGCORE24MRCG-CORE24-MR2022-10-06
B201CGSMM0Clear Guide SteriMASKCGSMMCG-SM-M2022-10-03
B201CGSCENERGY0Clear Guide SCENERGYCGSCENERGY2016-09-21
B201CGSM0Clear Guide SteriMASKCGSM2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05