Cleared Traditional

KBA3D

K223841 · S.M.A.I.O · Radiology
May 2023
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K223841 is an FDA 510(k) clearance for the KBA3D, 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 review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K223841 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050