Smart-C

FDA 510(k) K190024 · Turner Imaging Systems, Inc.

Substantially Equivalent

510(k) numberK190024

Submission

Device name
Smart-C
Applicant
Turner Imaging Systems, Inc.
Orem, UT, US
Received
January 7, 2019
Decision date
September 27, 2019
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Fluoroscopy of the human body.

Other 510(k)s with product code OXO

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K253296Digital C-ARM with 3DOXO · Traditional Allengers Medical Systems Limited06/05/2026SE
K252579Orthoscan TAU MVP Mini C-Arm SystemOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2026SE
K253269OEC One CFDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.11/26/2025SE
K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional Hefei Chimed Intelligent Machine Co., Ltd.11/06/2025SE
K250587Orthoscan TAU Mini C-ArmOXO · Special Ziehm-Orthoscan, Inc.07/02/2025SE
K243452Orthoscan VERSA Mini C-ArmOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2025SE
K240828OEC One ASDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.12/27/2024SE
K233669Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/28/2024SE
K213113Orthoscan Tau Mini C-ArmOXO · Special Orthoscan, Inc.10/21/2021SE
K203346Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/05/2021SE

Questions and answers

When was Smart-C cleared by the FDA?

Smart-C (K190024) received a 510(k) decision of Substantially Equivalent on September 27, 2019, 263 days after the submission was received.

What is the product code of K190024?

The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.