Segment

GUDID 07350010100010

Software for medical image analysis.

Medviso AB

Radiology DICOM image processing application software

• Primary Device ID: 07350010100010
• NIH Device Record Key: bbec76f1-cab6-4e3a-a3cc-65c50b69a5e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Segment
• Version Model Number: 2
• Company DUNS: 554436829
• Company Name: Medviso AB
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350010100010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090833

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-03-08

Devices Manufactured by Medviso AB

• 07350010100041 - Segment 3DPrint: 2023-11-08
• 07350010100010 - Segment: 2019-10-07Software for medical image analysis.
• 07350010100010 - Segment: 2019-10-07 Software for medical image analysis.
• 07350010100027 - Segment CMR: 2018-07-06 Software for cardiac image analysis.