KBA3D

FDA 510(k) K223841 · S.M.A.I.O

Substantially Equivalent

510(k) numberK223841

Submission

Device name
KBA3D
Applicant
S.M.A.I.O
Saint-Priest, FR
Received
December 22, 2022
Decision date
May 30, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

Other 510(k)s with product code LLZ

510(k)DeviceApplicantDecision
K2620603D-RD-SLLZ · Traditional Radiopharmaceutical Imaging & Dosimetry, LLC09/04/2026SE
K261500KBA3D (v2.4.0)LLZ · Traditional S.M.A.I.O08/17/2026SE
K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
K261916NeuroQuant PETLLZ · Traditional Cortechs Labs, Inc.08/12/2026SE
K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
K260588Cleerly LABSLLZ · Traditional Cleerly, Inc.07/29/2026SE
K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K262120Avara ViewerLLZ · Traditional Avara Software07/10/2026SE

More from Avara Software

510(k)DeviceDecision
K262828KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special 09/04/2026SE
K261500KBA3D (v2.4.0)LLZ · Traditional 08/17/2026SE
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special 07/01/2026SE
K260786KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special 04/03/2026SE
K253990KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special 01/07/2026SE
K253721KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special 12/17/2025SE
K251804KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special 07/08/2025SE
K232650KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special 09/29/2023SE
K211981KHEIRON® Spinal Fixation SystemNKB · Traditional 06/09/2022SE
K213975KEOPS Balance Analyzer 3DLLZ · Traditional 05/06/2022SE

Questions and answers

When was KBA3D cleared by the FDA?

KBA3D (K223841) received a 510(k) decision of Substantially Equivalent on May 30, 2023, 159 days after the submission was received.

What is the product code of K223841?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.