FDA.reportPublic FDA data

ECO Series Diagnostic Ultrasound Systems

Primary DI
06945121407915
Brand
ECO Series Diagnostic Ultrasound Systems
Company
CHISON Medical Technologies Co., Ltd.
Model
ECO 1
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K131305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131305000CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBEChison Medical Imaging Co., Ltd.2013-08-01IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121407847PackageGS11In Commercial Distribution
06945121407854PackageGS11In Commercial Distribution
06945121407861PackageGS11In Commercial Distribution
06945121407878PackageGS11In Commercial Distribution
06945121407885PackageGS11In Commercial Distribution
06945121407892PackageGS11In Commercial Distribution
06945121407908PackageGS11In Commercial Distribution
06945121407915PackageGS11In Commercial Distribution
06945121407311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121407847069451214078476945121407847
06945121407854069451214078546945121407854
06945121407861069451214078616945121407861
06945121407878069451214078786945121407878
06945121407885069451214078856945121407885
06945121407892069451214078926945121407892
06945121407908069451214079086945121407908
06945121407915069451214079156945121407915
06945121407311069451214073116945121407311

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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