FDA.reportPublic FDA data

QBit Series Diagnostic Ultrasound System

Primary DI
06945121403221
Brand
QBit Series Diagnostic Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
QBit 5
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
06945121404396PackageGS11In Commercial Distribution
06945121404402PackageGS11In Commercial Distribution
06945121404419PackageGS11In Commercial Distribution
06945121404426PackageGS11In Commercial Distribution
06945121404433PackageGS11In Commercial Distribution
06945121404440PackageGS11In Commercial Distribution
06945121404457PackageGS11In Commercial Distribution
06945121404464PackageGS11In Commercial Distribution
06945121404471PackageGS11In Commercial Distribution
06945121404488PackageGS11In Commercial Distribution
06945121404495PackageGS11In Commercial Distribution
06945121404501PackageGS11In Commercial Distribution
06945121404518PackageGS11In Commercial Distribution
06945121404525PackageGS11In Commercial Distribution
06945121404532PackageGS11In Commercial Distribution
06945121404549PackageGS11In Commercial Distribution
06945121404556PackageGS11In Commercial Distribution
06945121404563PackageGS11In Commercial Distribution
06945121404570PackageGS11In Commercial Distribution
06945121404587PackageGS11In Commercial Distribution
06945121404594PackageGS11In Commercial Distribution
06945121404600PackageGS11In Commercial Distribution
06945121404617PackageGS11In Commercial Distribution
06945121404624PackageGS11In Commercial Distribution
06945121404631PackageGS11In Commercial Distribution
06945121404648PackageGS11In Commercial Distribution
06945121404655PackageGS11In Commercial Distribution
06945121403221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121404396069451214043966945121404396
06945121404402069451214044026945121404402
06945121404419069451214044196945121404419
06945121404426069451214044266945121404426
06945121404433069451214044336945121404433
06945121404440069451214044406945121404440
06945121404457069451214044576945121404457
06945121404464069451214044646945121404464
06945121404471069451214044716945121404471
06945121404488069451214044886945121404488
06945121404495069451214044956945121404495
06945121404501069451214045016945121404501
06945121404518069451214045186945121404518
06945121404525069451214045256945121404525
06945121404532069451214045326945121404532
06945121404549069451214045496945121404549
06945121404556069451214045566945121404556
06945121404563069451214045636945121404563
06945121404570069451214045706945121404570
06945121404587069451214045876945121404587
06945121404594069451214045946945121404594
06945121404600069451214046006945121404600
06945121404617069451214046176945121404617
06945121404624069451214046246945121404624
06945121404631069451214046316945121404631
06945121404648069451214046486945121404648
06945121404655069451214046556945121404655
06945121403221069451214032216945121403221

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