FDA.reportPublic FDA data

SonoBook Series Diagnostic Ultrasound Systems

Primary DI
06945121413305
Brand
SonoBook Series Diagnostic Ultrasound Systems
Company
CHISON Medical Technologies Co., Ltd.
Model
SonoBook 7
Published
2021-09-27
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
K170374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170374000SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.2017-06-06IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945121413589PackageGS11In Commercial Distribution
06945121414241PackageGS11In Commercial Distribution
06945121414258PackageGS11In Commercial Distribution
06945121415163PackageGS11In Commercial Distribution
06945121415170PackageGS11In Commercial Distribution
06945121415446PackageGS11In Commercial Distribution
06945121415576PackageGS11In Commercial Distribution
06945121415583PackageGS11In Commercial Distribution
06945121415590PackageGS11In Commercial Distribution
06945121415606PackageGS11In Commercial Distribution
06945121413305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945121413589069451214135896945121413589
06945121414241069451214142416945121414241
06945121414258069451214142586945121414258
06945121415163069451214151636945121415163
06945121415170069451214151706945121415170
06945121415446069451214154466945121415446
06945121415576069451214155766945121415576
06945121415583069451214155836945121415583
06945121415590069451214155906945121415590
06945121415606069451214156066945121415606
06945121413305069451214133056945121413305

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
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
06945121414609SonoAir Series Digital Color Doppler Ultrasound SystemSonoAir 702023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYN2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
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/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYN2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
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.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
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