# K202718: Qmenta Care Platform Family

- Pathway: 510(k) (Traditional)
- Applicant: Mint Labs, Inc., D/B/A. Qmenta
- Decided: Jun 16, 2021 after 272 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K142337 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142337: Blackford Analysis Registration Product Family, Blackford Analysis, Ltd. (2015) Summary page 5.

## Indications for use
QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. QMENTA Care Platform Family consists of two components: 1. A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage. 2. A workflow server that allows to integrate legally marketed applications for clinical use into the QMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names. The results may be saved to a DICOM image file and may be further visualized on an imaging workstation. QMENTA Care Platform Family is designed to aid suitably qualified physicians, who will base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications.

Source page: https://510kreport.com/device/K202718
Methodology: https://510kreport.com/methodology