mintLesion®

Primary DI
04260495880365
Brand
mintLesion®
Company
Mint Medical GmbH
Model
3.6.0
Device description
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.
Published
2019-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142647000mint LesionMint Medical GmbH2015-04-13LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260495880358PreviousGS10
04260495880365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260495880358042604958803584260495880358
04260495880365042604958803654260495880365

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Contacts#

Phone, Email table
PhoneEmail
+4962216479769support@mint-medical.com

Regulatory Flags#

DUNS number
341622633
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260495883120mintLesion™3.12.02026-04-02
04260495883113mintLesion™3.11.02025-04-09
04260495883106mintLesion™3.10.02024-10-16
04260495880396mintLesion™3.9.02023-03-08
04260495880389mintLesion™3.8.02021-07-02
04260495880372mintLesion®3.7.02020-03-25
04260495880358mintLesion®3.5.02019-07-26
14260495880331mintLesion®3.3.02017-05-29
04260495880341mintLesion®3.4.02018-01-17

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