Cleared Traditional

DTX Studio Assist

K252086 · Nobel Biocare C/O Medicim NV · Radiology
Nov 2025
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K252086 is an FDA 510(k) clearance for the DTX Studio Assist, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by Nobel Biocare C/O Medicim NV (Mechelen, BE). The FDA issued a Cleared decision on November 17, 2025, 138 days after receiving the submission on July 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K252086 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2025
Decision Date November 17, 2025
Days to Decision 138 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