FDA.reportPublic FDA data

Q Series Diagnostic Ultrasound System

Primary DI
06945121400060
Brand
Q Series Diagnostic Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
Q9
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
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
06945121402064PackageGS11In Commercial Distribution
06945121402071PackageGS11In Commercial Distribution
06945121402088PackageGS11In Commercial Distribution
06945121402095PackageGS11In Commercial Distribution
06945121402101PackageGS11In Commercial Distribution
06945121402118PackageGS11In Commercial Distribution
06945121402125PackageGS11In Commercial Distribution
06945121402132PackageGS11In Commercial Distribution
06945121402149PackageGS11In Commercial Distribution
06945121402156PackageGS11In Commercial Distribution
06945121402163PackageGS11In Commercial Distribution
06945121402170PackageGS11In Commercial Distribution
06945121402187PackageGS11In Commercial Distribution
06945121402194PackageGS11In Commercial Distribution
06945121402200PackageGS11In Commercial Distribution
06945121402217PackageGS11In Commercial Distribution
06945121402224PackageGS11In Commercial Distribution
06945121402231PackageGS11In Commercial Distribution
06945121402248PackageGS11In Commercial Distribution
06945121402255PackageGS11In Commercial Distribution
06945121402262PackageGS11In Commercial Distribution
06945121402279PackageGS11In Commercial Distribution
06945121402286PackageGS11In Commercial Distribution
06945121402293PackageGS11In Commercial Distribution
06945121402309PackageGS11In Commercial Distribution
06945121402316PackageGS11In Commercial Distribution
06945121402323PackageGS11In Commercial Distribution
06945121402330PackageGS11In Commercial Distribution
06945121400060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121402064069451214020646945121402064
06945121402071069451214020716945121402071
06945121402088069451214020886945121402088
06945121402095069451214020956945121402095
06945121402101069451214021016945121402101
06945121402118069451214021186945121402118
06945121402125069451214021256945121402125
06945121402132069451214021326945121402132
06945121402149069451214021496945121402149
06945121402156069451214021566945121402156
06945121402163069451214021636945121402163
06945121402170069451214021706945121402170
06945121402187069451214021876945121402187
06945121402194069451214021946945121402194
06945121402200069451214022006945121402200
06945121402217069451214022176945121402217
06945121402224069451214022246945121402224
06945121402231069451214022316945121402231
06945121402248069451214022486945121402248
06945121402255069451214022556945121402255
06945121402262069451214022626945121402262
06945121402279069451214022796945121402279
06945121402286069451214022866945121402286
06945121402293069451214022936945121402293
06945121402309069451214023096945121402309
06945121402316069451214023166945121402316
06945121402323069451214023236945121402323
06945121402330069451214023306945121402330
06945121400060069451214000606945121400060

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
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278723963NAGE Healthcare Japan CorporationIYO2025-10-15
00195278723963NAGE Healthcare Japan CorporationIYN2025-10-15
00884838129276Ultrasound WorkspacePhilips Ultrasound LLCIYN2025-08-29
00195278875860VscanGE Vingmed Ultrasound A/SIYN2025-07-04
00195278875860VscanGE Vingmed Ultrasound A/SIYO2025-07-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYN2025-06-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYO2025-06-04
00884838125186Ultrasound WorkspacePhilips Ultrasound LLCIYN2025-03-24
00195278814685VolusonGE Healthcare Austria GmbH & Co OGIYO2025-01-08
00195278814685VolusonGE Healthcare Austria GmbH & Co OGIYN2025-01-08