Cleared Traditional

maiLink (K253008) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253008 · Maihub Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
108d
Days
Class 2
Risk

K253008 is an FDA 510(k) clearance for the maiLink. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Maihub Corp. (Seoul, KR). The FDA issued a Cleared decision on January 5, 2026 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Maihub Corp. devices

Submission Details

510(k) Number K253008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date January 05, 2026
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K253008.
LiveMedica Enterprise PACS
K253927 · Live Medica, LLC · Feb 2026
View
K253639 · Ge Healthcare · Jan 2026
3DICOM MD Cloud
K253784 · Singular Health Pty, Ltd. · Jan 2026
MIM – LesionID Pro
K251883 · Mim Software, Inc. · Dec 2025
Archy Dental Imaging
K251880 · Archy Dental, Inc. · Nov 2025
syngo.MR Applications (VB80)
K253495 · Siemens Healthineers AG · Nov 2025