FDA.reportPublic FDA data

Medisono

Primary DI
B369MUS01026
Brand
Medisono
Company
Medisono, LLC
Model
P9 PLUS
Catalog number
MUS01026
Published
2020-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
B369MUS01026PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(305)406-3931Fernando.ramon@medisono.com

Regulatory Flags#

DUNS number
079686615
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B369MUS05001MedisonoCONVEX ARRAY PROBE MODEL PB-C361-2 FOR MEDISONO P3MUS050012020-12-28
B369MUS05002MedisonoLINEAR ARRAY PROBE MODEL PB-L761-2 FOR MEDISONO P3MUS050022020-12-28
B369MUS05003MedisonoLINEAR ARRAY PROBE MODEL PB-L743-2 FOR MEDISONO P3MUS050032020-12-28
B369MUS05004MedisonoMICRO-CONVEX PROBE MODEL PB-C611-2 FOR MEDISONO P3MUS050042020-12-28
B369MUS05005MedisonoTRANSVAGINAL PROBE MODEL PB-E611-2 FOR MEDISONO P3MUS050052020-12-28
B369MUS05006MedisonoENDORECTAL PROBE MODEL PB-E741-2 FOR MEDISONO P3MUS050062020-12-28
B369MUS05007MedisonoENDORECTAL PROBE MODEL PB-V563-2 FOR MEDISONO P3VMUS050072020-12-28
B369MUS05008MedisonoCONVEX ARRAY PROBE MODEL PB-C361-2 FOR MEDISONO P3MUS050082020-12-28
B369MUS05009MedisonoLINEAR ARRAY PROBE MODEL PB-L761-2 FOR MEDISONO P3MUS050092020-12-28
B369MUS05010MedisonoLINEAR ARRAY PROBE MODEL PB-L743-2 FOR MEDISONO P3MUS050102020-12-28
B369MUS05011MedisonoMICRO-CONVEX PROBE MODEL PB-C611-2 FOR MEDISONO P3MUS050112020-12-28
B369MUS05020MedisonoCONVEX ARRAY PROBE MODEL PB-C352UB FOR MEDISONO P1MUS050202020-12-28
B369MUS05021MedisonoMICRO-CONVEX ARRAY PROBE MODEL PB-C612UB FOR MEDISMUS050212020-12-28
B369MUS05022MedisonoMICRO-CONVEX ARRAY PROBE MODEL PB-C422UB FOR MEDISMUS050222020-12-28
B369MUS05023MedisonoLINEAR ARRAY PROBE MODEL PB-L742UB FOR MEDISONO P1MUS050232020-12-28
B369MUS05024MedisonoLINEAR ARRAY PROBE MODEL PB-L1042UB FOR MEDISONO PMUS050242020-12-28
B369MUS05025MedisonoLINEAR ARRAY PROBE MODEL PB-L552UB FOR MEDISONO P1MUS050252020-12-28
B369MUS05026MedisonoTRANSVAGINAL ARRAY PROBE MODEL PB-E612UB FOR MEDISMUS050262020-12-28
B369MUS05030MedisonoCONVEX ARRAY PROBE MODEL PB-C352UB FOR MEDISONO P1MUS050302020-12-28
B369MUS05031MedisonoMICRO-CONVEX ARRAY PROBE MODEL PB-C612UB FOR MEDISMUS050312020-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042849CA1-7SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
08800013544001X-CUBE 50Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013545008X-CUBE 60Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013511171C1-6CAlpinion Medical Systems Co., Ltd.IYN2022-07-15
08800013511164C1-7GTAlpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013542007X-CUBE i8Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013543004X-CUBE i9Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800076600119SC1FCUIYN2021-11-01
08800076600133Sono ChampionFCUIYN2021-11-01
08800076600140Sono ChangerFCUIYN2021-11-01
08800076600157Sono dot AIFCUIYN2021-11-01
08800076600010eZono1000FCUIYN2021-10-29
08800076600027Sonovation1LFCUIYN2021-10-29
08800076600034SOFRA1LFCUIYN2021-10-29
08800076600041SonoInfra1LFCUIYN2021-10-29
08800076600058Dr.SAFEFCUIYN2021-10-29
08800076600065ACUFRIENDFCUIYN2021-10-29
08800076600072ACUGUIDEFCUIYN2021-10-29
08800076600089ACUWAYFCUIYN2021-10-29
08800076600096AcuViz PocketFCUIYN2021-10-29