3Dicom MD v3.5.2

GUDID 09309000371006

SINGULAR HEALTH PTY LTD

Radiology picture archiving and communication system workstation

• Primary Device ID: 09309000371006
• NIH Device Record Key: 9d00ad93-0283-4eaf-8077-30b11fcec43b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Dicom MD
• Version Model Number: 3Dicom MD
• Catalog Number: v3.5.2
• Company DUNS: 746825698
• Company Name: SINGULAR HEALTH PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	09309000371006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222470

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: 2025-01-30
• Device Publish Date: 2025-01-22