FDA.reportPublic FDA data

CBit Series Digital Color Doppler Ultrasound System

Primary DI
06945121412308
Brand
CBit Series Digital Color Doppler Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
CBit 8
Published
2018-08-27
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
K180974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180974000CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.2018-08-17IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121412384PackageGS11In Commercial Distribution
06945121412391PackageGS11In Commercial Distribution
06945121412407PackageGS11In Commercial Distribution
06945121412414PackageGS11In Commercial Distribution
06945121412421PackageGS11In Commercial Distribution
06945121412438PackageGS11In Commercial Distribution
06945121412445PackageGS11In Commercial Distribution
06945121412452PackageGS11In Commercial Distribution
06945121412469PackageGS11In Commercial Distribution
06945121412476PackageGS11In Commercial Distribution
06945121412483PackageGS11In Commercial Distribution
06945121412490PackageGS11In Commercial Distribution
06945121412506PackageGS11In Commercial Distribution
06945121412513PackageGS11In Commercial Distribution
06945121412520PackageGS11In Commercial Distribution
06945121412537PackageGS11In Commercial Distribution
06945121412544PackageGS11In Commercial Distribution
06945121412551PackageGS11In Commercial Distribution
06945121412568PackageGS11In Commercial Distribution
06945121412575PackageGS11In Commercial Distribution
06945121412582PackageGS11In Commercial Distribution
06945121412599PackageGS11In Commercial Distribution
06945121412605PackageGS11In Commercial Distribution
06945121412612PackageGS11In Commercial Distribution
06945121412629PackageGS11In Commercial Distribution
06945121412636PackageGS11In Commercial Distribution
06945121412643PackageGS11In Commercial Distribution
06945121412650PackageGS11In Commercial Distribution
06945121412667PackageGS11In Commercial Distribution
06945121412308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121412384069451214123846945121412384
06945121412391069451214123916945121412391
06945121412407069451214124076945121412407
06945121412414069451214124146945121412414
06945121412421069451214124216945121412421
06945121412438069451214124386945121412438
06945121412445069451214124456945121412445
06945121412452069451214124526945121412452
06945121412469069451214124696945121412469
06945121412476069451214124766945121412476
06945121412483069451214124836945121412483
06945121412490069451214124906945121412490
06945121412506069451214125066945121412506
06945121412513069451214125136945121412513
06945121412520069451214125206945121412520
06945121412537069451214125376945121412537
06945121412544069451214125446945121412544
06945121412551069451214125516945121412551
06945121412568069451214125686945121412568
06945121412575069451214125756945121412575
06945121412582069451214125826945121412582
06945121412599069451214125996945121412599
06945121412605069451214126056945121412605
06945121412612069451214126126945121412612
06945121412629069451214126296945121412629
06945121412636069451214126366945121412636
06945121412643069451214126436945121412643
06945121412650069451214126506945121412650
06945121412667069451214126676945121412667
06945121412308069451214123086945121412308

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

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