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510(k) Data Aggregation
K Number
K190024Device Name
Smart-C
Manufacturer
Turner Imaging Systems, Inc.
Date Cleared
2019-09-27
(263 days)
Product Code
OXO, JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Turner Imaging Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smart-C is a mini C-arm X-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.
Device Description
The Smart-C is an ultra-portable, battery-powered, mobile fluoroscopic mini C-arm system. The main component is a mini C-arm that consists of a CMOS flat panel detector aligned with an X-ray source monoblock to be used for image acquisition. The system can be hand-transported for imaging at the point of care. The primary operator workstation is a tablet computer that receives the images from the C-arm via wireless transfer protocol. The system includes a wireless footswitch to initiate image acquisition, making the entire system cord-free during operation. It comes with 2 battery packs, a table-top battery charger, and a tablet docking station. An optional Monitor Cart is provided as an accessory. The Smart-C monitor cart includes a 27" full-color touchscreen monitor, a keyboard for data entry, a printer for hard-copy of the x-ray images, and a battery charger for the Smart-C battery packs. The whole cart is battery-powered, to provide a completely cord-free user experience.
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