FDA.reportPublic FDA data

cV5 Diagnostic Ultrasound System

Primary DI
08800289981883
Brand
cV5 Diagnostic Ultrasound System
Company
SAMSUNG MEDISON CO., LTD.
Model
cV5
Published
2025-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250999000V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2025-07-18IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800289981883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800289981883088002899818838800289981883

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
687785691
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800289979132cV4 Diagnostic Ultrasound SystemcV42025-09-03
08806167766030LA3-16ADLA3-16AD2025-09-03
08809944906476LM2-18DLM2-18D2025-09-03
08809944942450miniER7miniER72025-09-03
08800290027266PA2-9SUSP-P029NSA/WR2026-04-03
08800290027419LA2-9SDUSP-LF29NSA/WR2026-04-03
08800290028638CA2-8ADUSP-C028N7B/WW2026-04-03
08800290029390EV2-10AUSP-V02AN1B/WW2026-04-03
08800290029420CV1-8AEUSP-VN18NSC/WW2026-04-03
08800290029512LA3-16ADUSP-L03GN4B/WW2026-04-03
08800290029604L3-22USP-LF3MN2A/WW2026-04-03
08800290029611LA3-22AIUSP-L03MN2A/WW2026-04-03
08800290029741EA2-11AVEUSP-EK2BN1B/WW2026-04-03
08800290029789EA2-11AREUSP-EG2BN1B/WW2026-04-03
08800290029826CA4-10MUSP-C04AN2A/WW2026-04-03
08800290029857CA1-7SDUSP-CF17N6A/WW2026-04-03
08800290032710LA2-16SCUSP-L02GNCA/WR2026-04-03
08800290032819LA3-16ADCUSP-L03GNCB/WR2026-04-03
08800290033373PA1-5AEDUSP-PN15N0A/WR2026-04-03
08800290035971TA2-9USP-M029NMA/WW2026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00850059977637TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977644TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977651TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977668TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977675TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
75401622522125Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-08-07
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
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
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYN2025-12-05
00811852030363Viz Subdural+VIZ.AI, INC.QIH2025-07-07