LMS-Liver

GUDID 03760263520024

LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.

MEDIAN TECHNOLOGIES

Radiological PACS software

• Primary Device ID: 03760263520024
• NIH Device Record Key: 66790a9e-52ae-4548-87f2-8a6e5f339fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMS-Liver
• Version Model Number: 6.0
• Company DUNS: 265359856
• Company Name: MEDIAN TECHNOLOGIES
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• 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	03760263520024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071241

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: 6
• Public Version Date: 2023-10-18
• Device Publish Date: 2016-09-14

Devices Manufactured by MEDIAN TECHNOLOGIES

• 03760263520017 - LMS-Lung/TRACK: 2023-10-18 LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - v
• 03760263520024 - LMS-Liver: 2023-10-18LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
• 03760263520024 - LMS-Liver: 2023-10-18 LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist