FDA.reportPublic FDA data

QBit Series Diagnostic Ultrasound System

Primary DI
06945121403245
Brand
QBit Series Diagnostic Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
QBit 7
Published
2016-09-24
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150861000QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.2015-07-28IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121404938PackageGS11In Commercial Distribution
06945121404945PackageGS11In Commercial Distribution
06945121404952PackageGS11In Commercial Distribution
06945121404969PackageGS11In Commercial Distribution
06945121404976PackageGS11In Commercial Distribution
06945121404983PackageGS11In Commercial Distribution
06945121404990PackageGS11In Commercial Distribution
06945121405003PackageGS11In Commercial Distribution
06945121405010PackageGS11In Commercial Distribution
06945121405027PackageGS11In Commercial Distribution
06945121405034PackageGS11In Commercial Distribution
06945121405041PackageGS11In Commercial Distribution
06945121405058PackageGS11In Commercial Distribution
06945121405065PackageGS11In Commercial Distribution
06945121405072PackageGS11In Commercial Distribution
06945121405089PackageGS11In Commercial Distribution
06945121405096PackageGS11In Commercial Distribution
06945121405102PackageGS11In Commercial Distribution
06945121405119PackageGS11In Commercial Distribution
06945121405126PackageGS11In Commercial Distribution
06945121405133PackageGS11In Commercial Distribution
06945121405140PackageGS11In Commercial Distribution
06945121405157PackageGS11In Commercial Distribution
06945121405164PackageGS11In Commercial Distribution
06945121405171PackageGS11In Commercial Distribution
06945121405188PackageGS11In Commercial Distribution
06945121405195PackageGS11In Commercial Distribution
06945121403245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121404938069451214049386945121404938
06945121404945069451214049456945121404945
06945121404952069451214049526945121404952
06945121404969069451214049696945121404969
06945121404976069451214049766945121404976
06945121404983069451214049836945121404983
06945121404990069451214049906945121404990
06945121405003069451214050036945121405003
06945121405010069451214050106945121405010
06945121405027069451214050276945121405027
06945121405034069451214050346945121405034
06945121405041069451214050416945121405041
06945121405058069451214050586945121405058
06945121405065069451214050656945121405065
06945121405072069451214050726945121405072
06945121405089069451214050896945121405089
06945121405096069451214050966945121405096
06945121405102069451214051026945121405102
06945121405119069451214051196945121405119
06945121405126069451214051266945121405126
06945121405133069451214051336945121405133
06945121405140069451214051406945121405140
06945121405157069451214051576945121405157
06945121405164069451214051646945121405164
06945121405171069451214051716945121405171
06945121405188069451214051886945121405188
06945121405195069451214051956945121405195
06945121403245069451214032456945121403245

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler system probeA hand-operated component of a foetal Doppler system which is placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.

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
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYN2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYN2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYN2026-07-24
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYN2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYN2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYN2026-07-10
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYN2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYN2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYN2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10