# K253008: maiLink

- Pathway: 510(k) (Traditional)
- Applicant: Maihub Corp.
- Decided: Jan 5, 2026 after 108 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: 9 generations back to K942120 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232891: Carpl (Carpl), Carpl Ai, Inc. (2024) Summary page 6.

## Indications for use
maiLink, a PACS and radiology workflow management software available as both a desktop/laptop application and a web viewer, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, secondary capture tools, imaging gateways. maiLink enables the storage, transmission, processing, and visualization of images and data within the system itself or over computer networks spanning different locations. Only pre-processed DICOM images specifically intended for presentation are suitable for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the maiLink. To ensure accurate interpretation, mammographic images should only be evaluated on a monitor that adheres to the technical specifications outlined by the FDA. This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.

Source page: https://510kreport.com/device/K253008
Methodology: https://510kreport.com/methodology