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510(k) Data Aggregation
K Number
K233200Device Name
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
Manufacturer
Date Cleared
2023-11-16
(49 days)
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Gemss Healthcare Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
XPlus 35 Series (XPLUS 35. XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures. i.e. surgical interventions needing X-ray imaging and interventions inside and outside the operating room.
Device Description
XPLUS 35 Series (XPLUS 35, XPLUS 35FD), C-arm mobile, is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. XPLUS 35 Series (XPLUS 35, XPLUS 35FD) consist of X-ray tube, X-ray generator, C-arm including image receptor, monitor cart, medical monitor and accessories such as foot switch and hand switch.
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K Number
K230800Device Name
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
Manufacturer
Date Cleared
2023-11-02
(224 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Gemss Healthcare Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XVISION-525 diagnostic X-ray system is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.
Device Description
The XVISION-525 diagnostic X-Ray System (Models HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50) generates medical X-rays passing through the patient's body and a X-ray detector for producing radiographic images of the human anatomical structures. The XVISION-525 diagnostic X-ray system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and a x-ray tube, that operates on a high-frequency inverter method. The user can select or change x-ray parameters easily using the operator control console. The AEC (Automatic Exposure Control) is an optional function to give the user control of exposure factors which can be optimized for different types of detectors selected, film or digital. The XVISION-525 X-ray system does not include a detector.
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