FDA.reportPublic FDA data

EBit Series Diagnostic Ultrasound System

Primary DI
06945121409704
Brand
EBit Series Diagnostic Ultrasound System
Company
CHISON Medical Technologies Co., Ltd.
Model
EBit 60
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
K162172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162172000EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.2016-09-14IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121410359PackageGS11In Commercial Distribution
06945121410366PackageGS11In Commercial Distribution
06945121410373PackageGS11In Commercial Distribution
06945121410380PackageGS11In Commercial Distribution
06945121410397PackageGS11In Commercial Distribution
06945121410403PackageGS11In Commercial Distribution
06945121410410PackageGS11In Commercial Distribution
06945121410427PackageGS11In Commercial Distribution
06945121410434PackageGS11In Commercial Distribution
06945121410441PackageGS11In Commercial Distribution
06945121410458PackageGS11In Commercial Distribution
06945121410465PackageGS11In Commercial Distribution
06945121410472PackageGS11In Commercial Distribution
06945121410489PackageGS11In Commercial Distribution
06945121410496PackageGS11In Commercial Distribution
06945121410502PackageGS11In Commercial Distribution
06945121410519PackageGS11In Commercial Distribution
06945121410526PackageGS11In Commercial Distribution
06945121410533PackageGS11In Commercial Distribution
06945121410540PackageGS11In Commercial Distribution
06945121410557PackageGS11In Commercial Distribution
06945121410564PackageGS11In Commercial Distribution
06945121410571PackageGS11In Commercial Distribution
06945121410588PackageGS11In Commercial Distribution
06945121410595PackageGS11In Commercial Distribution
06945121410601PackageGS11In Commercial Distribution
06945121410618PackageGS11In Commercial Distribution
06945121410625PackageGS11In Commercial Distribution
06945121410632PackageGS11In Commercial Distribution
06945121410649PackageGS11In Commercial Distribution
06945121410656PackageGS11In Commercial Distribution
06945121410663PackageGS11In Commercial Distribution
06945121409704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121410359069451214103596945121410359
06945121410366069451214103666945121410366
06945121410373069451214103736945121410373
06945121410380069451214103806945121410380
06945121410397069451214103976945121410397
06945121410403069451214104036945121410403
06945121410410069451214104106945121410410
06945121410427069451214104276945121410427
06945121410434069451214104346945121410434
06945121410441069451214104416945121410441
06945121410458069451214104586945121410458
06945121410465069451214104656945121410465
06945121410472069451214104726945121410472
06945121410489069451214104896945121410489
06945121410496069451214104966945121410496
06945121410502069451214105026945121410502
06945121410519069451214105196945121410519
06945121410526069451214105266945121410526
06945121410533069451214105336945121410533
06945121410540069451214105406945121410540
06945121410557069451214105576945121410557
06945121410564069451214105646945121410564
06945121410571069451214105716945121410571
06945121410588069451214105886945121410588
06945121410595069451214105956945121410595
06945121410601069451214106016945121410601
06945121410618069451214106186945121410618
06945121410625069451214106256945121410625
06945121410632069451214106326945121410632
06945121410649069451214106496945121410649
06945121410656069451214106566945121410656
06945121410663069451214106636945121410663
06945121409704069451214097046945121409704

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. 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
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYN2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYN2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953126073VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
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.IYN2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18