3D/5D VIEWER

GUDID 08806167754969

SAMSUNG MEDISON CO., LTD.

Ultrasound imaging system workstation

• Primary Device ID: 08806167754969
• NIH Device Record Key: c6ff2dea-e117-49b5-b0af-11514df1ca35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D/5D VIEWER
• Version Model Number: USO-U0NMI00/WR
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806167754969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151808

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-28
• Device Publish Date: 2026-01-20

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

• 08800289975974 - R30 Diagnostic Ultrasound System: 2026-01-28
• 08800289976025 - R20 Diagnostic Ultrasound System: 2026-01-28
• 08800289979224 - EA2-11ARn: 2026-01-28
• 08800289979262 - CA1-7Sn: 2026-01-28
• 08800290027297 - PA2-9S: 2026-01-28
• 08800290027334 - LA2-9Sn: 2026-01-28
• 08800290027365 - CA3-10An: 2026-01-28
• 08800290031522 - HERA Z20e Diagnostic Ultrasound System: 2026-01-28