mintLesion™

GUDID 04260495883113

The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients. mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate. mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)). mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications.

Mint Medical GmbH

Radiology DICOM image processing application software

• Primary Device ID: 04260495883113
• NIH Device Record Key: c5fefc0e-47cc-43e6-b6ad-6baac2a1cd31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mintLesion™
• Version Model Number: 3.11.0
• Company DUNS: 341622633
• Company Name: Mint Medical GmbH
• 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: 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	04260495883113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142647

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: 2025-04-17
• Device Publish Date: 2025-04-09

On-Brand Devices [mintLesion™]

• 04260495880389: The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatmen
• 04260495880396: The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatmen
• 04260495883106: The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatmen
• 04260495883113: The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatmen