Search Results
Found 3 results
510(k) Data Aggregation
K Number
K163140Device Name
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
Manufacturer
GEMSS MEDICAL SYSTEMS CO., LTD
Date Cleared
2017-05-26
(198 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GEMSS MEDICAL SYSTEMS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.
Device Description
The SPINEL 12HD Surgical Mobile Fluoroscopic 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 to be used for mammography applications. SPINEL 12HD is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and a flat panel detector. This system can be applied in emergency room, operation room, cast room or etc. of a hospital.
Ask a Question
K Number
K160065Device Name
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
Manufacturer
GEMSS MEDICAL SYSTEMS CO., LTD
Date Cleared
2016-05-20
(128 days)
Product Code
OXO, JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
GEMSS MEDICAL SYSTEMS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KMC-650 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 guided procedure & mammographic applications.
Device Description
The KMC-650 Surgical Mobile Fluoroscopic X-rav 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. Not to be used for mammography.
KMC-650 is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.
Ask a Question
K Number
K133695Device Name
TITAN 11
Manufacturer
GEMSS MEDICAL SYSTEMS CO., LTD
Date Cleared
2014-08-07
(247 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
GEMSS MEDICAL SYSTEMS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TITAN 11 is a diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. This device is not intended for mammography.
Device Description
TITAN 11, the high frequency inverter type of Radiographic system is operated by the built-in operation program. TITAN 11 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the SSXI detector, X-ray Generator, X-ray Collimator, PC, Detector Stand, Tube Stand, Mobile Table, PU-30(Power Supply) and viewing software. Optional devices include AEC, DAP, Hand or Foot Exposure Switch.
Ask a Question
Page 1 of 1