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510(k) Data Aggregation
K Number
K132289Device Name
GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
Manufacturer
Date Cleared
2014-06-16
(328 days)
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GEMSS MEDICAL SYSTEMS CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SPINEL 3G, Surgical Mobile Fluoroscopic X-ray system, is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not intended for interventional quided procedure & mammographic applications.
Device Description
The Image Intensified Fluroscopic X-ray System consists of a high voltage (HV) inverter generator, a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. This device is not intended for interventional quided procedure & mammographic applications.
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