Cleared Traditional

DTX Studio Clinic 3.0

K221921 · Nobel Biocare AB · Radiology

Mar 2023

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K221921 is an FDA 510(k) clearance for the DTX Studio Clinic 3.0, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by Nobel Biocare AB (411 17 Goteborg, SE). The FDA issued a Cleared decision on March 28, 2023, 270 days after receiving the submission on July 1, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number	K221921 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2022
Decision Date	March 28, 2023
Days to Decision	270 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