FDA.reportPublic FDA data

Q Series Diagnostic Ultrasound System

Primary DI
06945121400039
Brand
Q Series Diagnostic Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
Q5
Published
2016-09-20
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
K153085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153085000Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.2015-12-21IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121401227PackageGS11In Commercial Distribution
06945121401234PackageGS11In Commercial Distribution
06945121401241PackageGS11In Commercial Distribution
06945121401258PackageGS11In Commercial Distribution
06945121401265PackageGS11In Commercial Distribution
06945121401272PackageGS11In Commercial Distribution
06945121401289PackageGS11In Commercial Distribution
06945121401296PackageGS11In Commercial Distribution
06945121401302PackageGS11In Commercial Distribution
06945121401319PackageGS11In Commercial Distribution
06945121401326PackageGS11In Commercial Distribution
06945121401333PackageGS11In Commercial Distribution
06945121401340PackageGS11In Commercial Distribution
06945121401357PackageGS11In Commercial Distribution
06945121401364PackageGS11In Commercial Distribution
06945121401371PackageGS11In Commercial Distribution
06945121401388PackageGS11In Commercial Distribution
06945121401395PackageGS11In Commercial Distribution
06945121401401PackageGS11In Commercial Distribution
06945121401418PackageGS11In Commercial Distribution
06945121401425PackageGS11In Commercial Distribution
06945121401432PackageGS11In Commercial Distribution
06945121401449PackageGS11In Commercial Distribution
06945121401456PackageGS11In Commercial Distribution
06945121401463PackageGS11In Commercial Distribution
06945121401470PackageGS11In Commercial Distribution
06945121401487PackageGS11In Commercial Distribution
06945121401494PackageGS11In Commercial Distribution
06945121400039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121401227069451214012276945121401227
06945121401234069451214012346945121401234
06945121401241069451214012416945121401241
06945121401258069451214012586945121401258
06945121401265069451214012656945121401265
06945121401272069451214012726945121401272
06945121401289069451214012896945121401289
06945121401296069451214012966945121401296
06945121401302069451214013026945121401302
06945121401319069451214013196945121401319
06945121401326069451214013266945121401326
06945121401333069451214013336945121401333
06945121401340069451214013406945121401340
06945121401357069451214013576945121401357
06945121401364069451214013646945121401364
06945121401371069451214013716945121401371
06945121401388069451214013886945121401388
06945121401395069451214013956945121401395
06945121401401069451214014016945121401401
06945121401418069451214014186945121401418
06945121401425069451214014256945121401425
06945121401432069451214014326945121401432
06945121401449069451214014496945121401449
06945121401456069451214014566945121401456
06945121401463069451214014636945121401463
06945121401470069451214014706945121401470
06945121401487069451214014876945121401487
06945121401494069451214014946945121401494
06945121400039069451214000396945121400039

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
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

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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
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06903053124492Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
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06903053124829Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN2026-06-03
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