FDA.reportPublic FDA data

3D/5D VIEWER

Primary DI
08806167754969
Brand
3D/5D VIEWER
Company
SAMSUNG MEDISON CO., LTD.
Model
USO-U0NMI00/WR
Published
2026-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1518080003D/5D ViewerSamsung Medison Co., Ltd.2015-07-29LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806167754969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806167754969088061677549698806167754969

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system workstationA freestanding image processing workstation specifically designed to be networked with one or more diagnostic ultrasound imaging systems. It is sometimes considered to be a component to a picture archiving and communication system (PACS). An ultrasound workstation differs from the operator's console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more ultrasounds.

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
088061677611725D VIEWERUSO-U0N5B0B/WR2016-09-26
088061677894665D ViewerUSO-U0N5B0K/WR2018-05-26
08800010500840SonoSync+USO-SSPS200/SW2026-08-18
08800290029376CA2-13MUSP-C02DFSA/WW2026-08-18
08800290036169PA2-9SUSP-P029FSA/WW2026-08-18
08800290036237BCC2-13USP-B02DF1A/WW2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemV6 ONE2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemV7 ONE2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemV8 ONE2026-08-18
08800289979132cV4 Diagnostic Ultrasound SystemcV42025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemcV52025-09-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03