FDA.reportPublic FDA data

Medisono

Primary DI
B369MUS05153
Brand
Medisono
Company
Medisono, LLC
Model
BIPLANE PROBE MODEL BCL 10-5 FOR MEDISONO P11 PLUS
Catalog number
MUS05153
Published
2020-12-28
Public version status
Update
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
K152164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152164000S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.2015-08-28IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B369MUS05153PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rectal/vaginal ultrasound imaging transducerAn invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. 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 another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

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

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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
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00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.IYN2026-06-10
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