FDA.reportPublic FDA data

ClearScan®

Primary DI
B360CS2001
Brand
ClearScan®
Company
ESI CORPORATION
Model
CS200
Catalog number
CS200
Device description
ClearScan
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080119000CLEARSCANEsi, Inc.2008-02-21ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B360CS2001PackageHIBCC10In Commercial Distribution
B360CS2000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, image-enhancementA non-sterile sheath containing an extraluminal pocket/balloon portion intended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-473-2533sales@eyesurgin.com

Regulatory Flags#

DUNS number
829391734
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B360CS2000ClearScan®CS200CS2002016-09-24
B360011B12360Prager Ext Set A1236011B1236011B12362016-09-24
B360011B12630Prager Ext Set B1263011B1263011B12632016-09-24
B360PSVGS0PRAGER SHELL® P106SVGSP106SV GOLD SERIES2019-12-18
B360P1000Prager Shell®P-100P-1002016-09-24
B360P100AS0Prager Shell®P-100-AS P-100-AS 2016-09-24
B360P1010Prager Shell®P-101 P-101 2016-09-24
B360P10120Prager Shell®P-101-2 P-101-2 2016-09-24
B360P1020Prager Shell®P-102 P-102 2016-09-24
B360P10220Prager Shell®P-102-2 P-102-2 2016-09-24
B360P1030Prager Shell®P-103 P-103 2016-09-24
B360P103GS0Prager Shell®P-103GS P-103GS 2016-09-24
B360P103SV0Prager Shell®P-103SV P-103SV 2016-09-24
B360P1040Prager Shell®P-104 P-104 2016-09-24
B360P104GS0Prager Shell®P-104GS P-104GS 2016-09-24
B360P104SV0Prager Shell®P-104SV P-104SV 2016-09-24
B360P1050Prager Shell®P-105P-1052016-09-24
B360P1060Prager Shell®P-106 P-106 2016-09-24
B360P106GS0Prager Shell®P-106GS P-106GS 2016-09-24
B360P106SV0Prager Shell®P-106SV P-106SV 2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27