# K142647: mint Lesion

- Pathway: 510(k) (Traditional)
- Applicant: Mint Medical GmbH
- Decided: Apr 13, 2015 after 208 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 146 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111642: Onco Trac Model 1, 2, 4, Translational Sciences Corporation (2011) Summary page 5.
- K133644: Syngo.Via MI Workflows, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.

## Most influential descendants
- K220929: Excelsior (2022), 0 descendants of its own
- K202229: AI Metrics (2020), 0 descendants of its own

## Recalls of this device
- Jan 7, 2026 · Class II · Z-2068-2026: 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 patient
- Nov 15, 2024 · Class II · Z-0709-2025: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
- Nov 15, 2024 · Class II · Z-0710-2025: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

## Indications for use
Mint Lesion is a software solution intended to be used for viewing, manipulation, communication, storage, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM / DVD to be installed by trained service personnel. Mint Lesion is a medical diagnostic application for viewing, manipulation, 3D visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MPR, MIP and volume rendering. Mint Lesion enables visualization of information that would otherwise have to be visually compared disjointedly. Mint Lesion provides analytical tools to help the user assess, and document the stage of a disease and/or the response to therapy in accordance with user selected standards. Mint Lesion supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Mint Lesion is a complement to these standard procedures. Mint Lesion is not to be used in mammography.

Source page: https://510kreport.com/device/K142647
Methodology: https://510kreport.com/methodology