LMS-Lung/TRACK

GUDID 03760263520017

LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports.

MEDIAN TECHNOLOGIES

Radiological PACS software

• Primary Device ID: 03760263520017
• NIH Device Record Key: 1376f27c-7290-4465-82ca-77232f1d98f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMS-Lung/TRACK
• 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	03760263520017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070868

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: 2023-10-18LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to: - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports.
• 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: 2023-10-18 LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist