Cleared Traditional

Midmark Extraoral Imaging System (EOIS)

K201667 · Midmark Corporation · Radiology
Aug 2020
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K201667 is an FDA 510(k) clearance for the Midmark Extraoral Imaging System (EOIS), a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Midmark Corporation (Buffalo Grove, US). The FDA issued a Cleared decision on August 6, 2020, 48 days after receiving the submission on June 19, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K201667 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2020
Decision Date August 06, 2020
Days to Decision 48 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.