Cleared Traditional

K223841 - KBA3D (FDA 510(k) Clearance)

K223841 · S.M.A.I.O · Radiology device

May 2023

Decision

159d

Days

Class 2

Risk

K223841 is an FDA 510(k) clearance for the KBA3D. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by S.M.A.I.O (Saint-Priest, FR). The FDA issued a Cleared decision on May 30, 2023, 159 days after receiving the submission on December 22, 2022.

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

Submission Details

510(k) Number	K223841 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 22, 2022
Decision Date	May 30, 2023
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF