Mintlesion™

The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological…

Registry build 21.09.26

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.

16manufacturers in China registered for this device type
10catalogue numbers in this listing
1510(k) clearance
3recalls on this code

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LLZ
Manufacturer City Province Registered as Device types
Shantou Institute OF Ultrasonic Instruments Co., Ltd. Shantou Guangdong Contract manufacturer 8
iRay Imaging Technology (Haining) Limited Haining Zhejiang Contract manufacturer 6
Chison Medical Technologies Co., Ltd. Wuxi Jiangsu Contract manufacturer 5
Coretronic Projection (Kunshan) Corporation Kunshan Jiangsu Contract manufacturer 3
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shanghai, Medical Equipment Ltd. Shanghai Shanghai Contract manufacturer 10
Carestream Health, Inc., Global R&D Center Shanghai Shanghai Specification developer 8
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4

Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological

Record

Regulatory record for mintLesion™
Listed by Mint Medical Gmbh, Germany
FDA product code LLZ
Device type System, Image Processing, Radiological
Device class Class 2
Regulation 21 CFR 892.2050
Establishment Manufacturer
510(k) K142647
Record published 2026-04-02
Record revised 2023-10-18 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for mintLesion™
Catalogue number Size Status
3.12.0 In distribution
3.8.0 In distribution
3.11.0 In distribution
3.4.0 In distribution
3.3.0 In distribution
3.5.0 In distribution
3.9.0 In distribution
3.10.0 In distribution
3.7.0 In distribution
3.6.0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imagegrid Radiology Viewer System Candelis, Inc. 173
Tims System Foresight Imaging, LLC 159
System, Image Processing, Radiological Biomet Microfixation 146
RamSoft Ramsoft, Inc. 65
Joints Medstrat 62
OrthoView Meridian Technique Ltd 54
IPS KLS-Martin L.P. 48
NovaPACS Novarad Corp. 42
PointCloud Knee Instruments Unik Orthopedics, Inc 34
DTX Studio™ Clinic Nobel Biocare AB 34
Eaglesoft Patterson Technology Center 33
Medtronic Navigation Medtronic Navigation, Inc. 26

Showing 12 of 1,109. All products under System, Image Processing, Radiological

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K142647 2015-04-13

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of mintLesion™
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Mint Medical Gmbh 510(k) number 2026-01-07 Class II Under Investigation by firm If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while
performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
101 systems
Mint Medical Gmbh 510(k) number 2024-11-15 Class II Software design Some software versions have a malfunction
where they may show incorrect orientation labels for a specific subset of DICOM images.
65 units (13 US, 52 OUS)
Mint Medical Gmbh 510(k) number 2024-11-15 Class II Software design Some software versions have a malfunction
where they may show incorrect orientation labels for a specific subset of DICOM images.
18 units (7 US, 11 OUS)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer