# K250427: TAIMedImg DeepMets

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Medical Imaging Co., Ltd.
- Decided: May 28, 2025 after 103 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- 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: 16 generations back to K954874 (1996). 102 ancestors in all.
No later device cites it as a predicate yet.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203235: VBrain, Vysioneer, Inc. (2021) Summary page 5.

## Indications for use
TAIMedImg DeepMets is a software device intended to assist trained medical professionals by providing initial object contours on axial T1-weighted contrast-enhanced (T1WI+C) brain magnetic resonance (MR) images to accelerate workflow for radiation therapy treatment planning. TAIMedImg DeepMets is intended only for patients with known (imaging diagnosed) brain metastases (BM) when cancer cells spread from primary site to the brain. It is not intended to be used with images of other brain tumors or other body parts. The software is intended for use with BM lesions with a diameter of ≥ 10 mm. TAIMedImg DeepMets uses an artificial intelligence algorithm to contour images and offers automated segmentation for Gross Tumor Volume (GTV) contours of brain metastases. The software is an adjunctive tool and not intended for replacing the users’ current standard practice of manual contouring process. All automatic output generated by the software shall be thoroughly reviewed by a trained medical professional prior to delivering any therapy or treatment. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision. TAIMedImg DeepMets is intended to be used by medical professionals trained in the use of the device. Only DICOM images of adult patients are considered valid input. DeepMets does not support DICOM images of patients that have one of the following exclusions: (i) presence of prior craniotomy, (ii) patients with clinical imaging diagnosis of brain tumors other than BM, (iii) Images with patient motion: excessive motion leading to artifacts that make the scan technically inadequate. Medical professionals must finalize (confirm or modify) the contours generated by TAIMedImg DeepMets, as necessary, using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system.

Source page: https://510kreport.com/device/K250427
Methodology: https://510kreport.com/methodology