Cleared Traditional

K220684 - Oryx Cloud Imaging (FDA 510(k) Clearance)

K220684 · Oryx Dental Software, Inc. · Radiology device

Apr 2022

Decision

52d

Days

Class 2

Risk

K220684 is an FDA 510(k) clearance for the Oryx Cloud Imaging. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Oryx Dental Software, Inc. (Seattle, US). The FDA issued a Cleared decision on April 29, 2022, 52 days after receiving the submission on March 8, 2022.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K220684 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 2022
Decision Date	April 29, 2022
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF