Cleared Traditional

K222975 - Advantis Platform (FDA 510(k) Clearance)

K222975 · Advantis Medical Imaging Single Member P.C. · Radiology device

Mar 2023

Decision

154d

Days

Class 2

Risk

K222975 is an FDA 510(k) clearance for the Advantis Platform. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Advantis Medical Imaging Single Member P.C. (Athens, GR). The FDA issued a Cleared decision on March 1, 2023, 154 days after receiving the submission on September 28, 2022.

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

Submission Details

510(k) Number	K222975 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 2022
Decision Date	March 01, 2023
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF