Cleared Traditional

DTX Studio Clinic 3.0

K213562 · Nobel Biocare AB · Radiology
Mar 2022
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K213562 is an FDA 510(k) clearance for the DTX Studio Clinic 3.0, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Nobel Biocare AB (411 17 Goteborg, SE). The FDA issued a Cleared decision on March 25, 2022, 136 days after receiving the submission on November 9, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K213562 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2021
Decision Date March 25, 2022
Days to Decision 136 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