Cleared Traditional

Diagnocat

K252934 · DGNCT, LLC · Radiology
Jan 2026
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K252934 is an FDA 510(k) clearance for the Diagnocat, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by DGNCT, LLC (Miami, US). The FDA issued a Cleared decision on January 15, 2026, 122 days after receiving the submission on September 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K252934 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2025
Decision Date January 15, 2026
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MYN — Analyzer, Medical Image
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers