Cleared Traditional

DUO1 and DUO2

K241649 · Zinnovi, Inc. · Radiology

Jul 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K241649 is an FDA 510(k) clearance for the DUO1 and DUO2, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Zinnovi, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 5, 2024, 28 days after receiving the submission on June 7, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K241649 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2024
Decision Date	July 05, 2024
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF