FDA.reportPublic FDA data

EBit Series Diagnostic Ultrasound System

Primary DI
06945121410861
Brand
EBit Series Diagnostic Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
EBit 50
Published
2017-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162172000EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.2016-09-14IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121410878PackageGS11In Commercial Distribution
06945121410885PackageGS11In Commercial Distribution
06945121410892PackageGS11In Commercial Distribution
06945121410908PackageGS11In Commercial Distribution
06945121410915PackageGS11In Commercial Distribution
06945121410922PackageGS11In Commercial Distribution
06945121410939PackageGS11In Commercial Distribution
06945121410946PackageGS11In Commercial Distribution
06945121410953PackageGS11In Commercial Distribution
06945121410960PackageGS11In Commercial Distribution
06945121410977PackageGS11In Commercial Distribution
06945121410984PackageGS11In Commercial Distribution
06945121410991PackageGS11In Commercial Distribution
06945121411004PackageGS11In Commercial Distribution
06945121411011PackageGS11In Commercial Distribution
06945121411028PackageGS11In Commercial Distribution
06945121411035PackageGS11In Commercial Distribution
06945121411042PackageGS11In Commercial Distribution
06945121411059PackageGS11In Commercial Distribution
06945121411066PackageGS11In Commercial Distribution
06945121411073PackageGS11In Commercial Distribution
06945121411080PackageGS11In Commercial Distribution
06945121411097PackageGS11In Commercial Distribution
06945121411103PackageGS11In Commercial Distribution
06945121411110PackageGS11In Commercial Distribution
06945121411127PackageGS11In Commercial Distribution
06945121411134PackageGS11In Commercial Distribution
06945121411141PackageGS11In Commercial Distribution
06945121411158PackageGS11In Commercial Distribution
06945121411165PackageGS11In Commercial Distribution
06945121410861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121410878069451214108786945121410878
06945121410885069451214108856945121410885
06945121410892069451214108926945121410892
06945121410908069451214109086945121410908
06945121410915069451214109156945121410915
06945121410922069451214109226945121410922
06945121410939069451214109396945121410939
06945121410946069451214109466945121410946
06945121410953069451214109536945121410953
06945121410960069451214109606945121410960
06945121410977069451214109776945121410977
06945121410984069451214109846945121410984
06945121410991069451214109916945121410991
06945121411004069451214110046945121411004
06945121411011069451214110116945121411011
06945121411028069451214110286945121411028
06945121411035069451214110356945121411035
06945121411042069451214110426945121411042
06945121411059069451214110596945121411059
06945121411066069451214110666945121411066
06945121411073069451214110736945121411073
06945121411080069451214110806945121411080
06945121411097069451214110976945121411097
06945121411103069451214111036945121411103
06945121411110069451214111106945121411110
06945121411127069451214111276945121411127
06945121411134069451214111346945121411134
06945121411141069451214111416945121411141
06945121411158069451214111586945121411158
06945121411165069451214111656945121411165
06945121410861069451214108616945121410861

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544914187
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945121415644SonoAir Series Digital Color Doppler Ultrasound SystemSonoAir 202025-10-14
06945121415538Micro convex probeE6-T2024-11-26
06945121413237XBit Series Digital Color Doppler Ultrasound SystemXBit 702021-09-26
06945121413459XBit Series Digital Color Doppler Ultrasound SystemXBit 902021-11-02
06945121413787XBit Series Digital Color Doppler Ultrasound SystemXBit 802022-07-10
06945121413305SonoBook Series Diagnostic Ultrasound SystemsSonoBook 72021-09-27
06945121415200SonoMax Series Digital Color Doppler Ultrasound SystemSonoMax 72024-08-15
06945121415385Linear probeL8M5-T2024-09-14
06945121414883Micro convex probeC4-E112024-08-16
06945121414814SonoMax Series Digital Color Doppler Ultrasound SystemSonoMax 92024-08-15
06945121415187Digital Color Doppler Palm Ultrasound SystemSonoEye G62024-06-03
06945121415194Digital Color Doppler Palm Ultrasound SystemSonoEye G62024-06-03
06945121414487EBit Series Diagnostic Ultrasound SystemEBit 202022-12-06
06945121413145CBit Series Digital Color Doppler Ultrasound SystemCBit 42021-03-09
06945121414524SonoAir Series Digital Color Doppler Ultrasound SystemSonoAir 602023-08-07
06945121414531Convex probe3C2023-08-07
06945121414548Linear probe7L2023-08-07
06945121414555Phased array probe3S2023-08-07
06945121414562Convex probe6MC2023-08-07
06945121414579Micro convex probe6E2023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06903053124348Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124355Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124379Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124430Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124461Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124492Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124546Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124560Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124591Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124607Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124614Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124683Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124706Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124720Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124775Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
06903053124829Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
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00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
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08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYN2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
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