FDA.reportPublic FDA data

XBit Series Digital Color Doppler Ultrasound System

Primary DI
06945121413787
Brand
XBit Series Digital Color Doppler Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
XBit 80
Published
2022-07-10
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
K200780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200780000XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.2020-08-05IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121413794PackageGS11In Commercial Distribution
06945121413800PackageGS11In Commercial Distribution
06945121413886PackageGS11In Commercial Distribution
06945121413893PackageGS11In Commercial Distribution
06945121413909PackageGS11In Commercial Distribution
06945121413916PackageGS11In Commercial Distribution
06945121413923PackageGS11In Commercial Distribution
06945121413930PackageGS11In Commercial Distribution
06945121413947PackageGS11In Commercial Distribution
06945121413954PackageGS11In Commercial Distribution
06945121413961PackageGS11In Commercial Distribution
06945121413978PackageGS11In Commercial Distribution
06945121413985PackageGS11In Commercial Distribution
06945121413992PackageGS11In Commercial Distribution
06945121414012PackageGS11In Commercial Distribution
06945121414036PackageGS11In Commercial Distribution
06945121414210PackageGS11In Commercial Distribution
06945121414760PackageGS11In Commercial Distribution
06945121415392PackageGS11In Commercial Distribution
06945121415552PackageGS11In Commercial Distribution
06945121413787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121413794069451214137946945121413794
06945121413800069451214138006945121413800
06945121413886069451214138866945121413886
06945121413893069451214138936945121413893
06945121413909069451214139096945121413909
06945121413916069451214139166945121413916
06945121413923069451214139236945121413923
06945121413930069451214139306945121413930
06945121413947069451214139476945121413947
06945121413954069451214139546945121413954
06945121413961069451214139616945121413961
06945121413978069451214139786945121413978
06945121413985069451214139856945121413985
06945121413992069451214139926945121413992
06945121414012069451214140126945121414012
06945121414036069451214140366945121414036
06945121414210069451214142106945121414210
06945121414760069451214147606945121414760
06945121415392069451214153926945121415392
06945121415552069451214155526945121415552
06945121413787069451214137876945121413787

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.

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
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
06945121414609SonoAir Series Digital Color Doppler Ultrasound SystemSonoAir 702023-08-07

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Primary DI, Brand, Company table
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