FDA.reportPublic FDA data

MEDISONO

Primary DI
B369MUS05240
Brand
MEDISONO
Company
Medisono, LLC
Model
LINEAR ARRAY PROBE MODEL PB-L741 FOR MEDISONO MS12
Catalog number
MUS05240
Device description
LINEAR ARRAY PROBE MODEL PB-L741 FOR MEDISONO MS12EXP
Published
2023-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170303000E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.2017-05-19IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B369MUS05240PrimaryHIBCC0

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
13054063931nicolo.briante@strenamedical.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
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27