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510(k) K190024

Smart-C by Turner Imaging Systems, Inc. — Product Code OXO

K190024 is an FDA 510(k) premarket notification submitted by Turner Imaging Systems, Inc. for the device "Smart-C". The FDA issued a decision of Substantially Equivalent on September 27, 2019. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2019
Date Received
January 7, 2019
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Fluoroscopy of the human body.

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  • K253269 — OEC One CFD (November 26, 2025)
  • K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (November 6, 2025)
  • K250587 — Orthoscan TAU Mini C-Arm (July 2, 2025)
  • K243452 — Orthoscan VERSA Mini C-Arm (January 14, 2025)
  • K240828 — OEC One ASD (December 27, 2024)
  • K233669 — OEC 3D (March 28, 2024)
  • K213113 — Orthoscan Tau Mini C-Arm (October 21, 2021)
  • K203346 — OEC 3D (March 5, 2021)

FDA data resources