Cleared Traditional

DTX Studio Clinic

K203156 · Nobel Biocare AB · Radiology
Nov 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K203156 is an FDA 510(k) clearance for the DTX Studio Clinic, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on November 20, 2020, 29 days after receiving the submission on October 22, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K203156 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2020
Decision Date November 20, 2020
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050