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Found 4 results
510(k) Data Aggregation
K Number
K193535Device Name
EZER, Portable X-ray System
Manufacturer
Livermoretech Inc.
Date Cleared
2020-05-07
(139 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Livermoretech Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZER Portable X-Ray system is a portable x-ray source with a fixed tube current and voltage for producing diagnostic x-ray images of extremities using digital or film image receptors. Its use is intended to be used by trained clinician or technicians for both adult and pediatric subjects age 2 and above.
It is not intended to replace a radiographic system with variable tube current and voltage (KVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
Device Description
EZER Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kVp) in order to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head. X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates extremities and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric patients.
The embedded 7" TFT display in EZER Portable X-ray is not intended to be used for diagnosis.
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K Number
K200022Device Name
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
Manufacturer
LiverMoreTech Inc.
Date Cleared
2020-04-03
(88 days)
Product Code
OWB, IZI, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
LiverMoreTech Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FLUSION-9001 fluoroscopic C-arm Mobile 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, orthopedical, abdominal, vascular, cardias, critical care and emergency room procedures.
Device Description
The FLUSION-9001 fluoroscopic C-arm Mobile 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.
FLUSION-9001 fluoroscopic C-arm Mobile X-ray System 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.
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K Number
K190935Device Name
EZER, Portable X-ray System
Manufacturer
Livermoretech Inc.
Date Cleared
2019-12-19
(253 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Livermoretech Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZER Portable X-Ray system is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Device Description
EZER Portable X-ray System generates and controls X-ray in order to diagnose of tooth and iaw. It operates on 22.2VDC supplied by a rechargeable Lithum-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single hand-held enclosure. EZER Portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting cone, and a remote control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates tooth and makes x-ray images on receptor. INTEL stick PC is integrated with EZER so the user can see X-ray image from LCD display without a computer. EZER Portable X-ray System is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects.
The embedded 7' TFT display in EZER Portable X-ray is not intended to be used for diagnosis.
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K Number
K180663Device Name
LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
Manufacturer
LIVERMORETECH Inc.
Date Cleared
2018-05-18
(65 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
LIVERMORETECH Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LaVid FMTS System is a stationery X-ray system intended for obtaining radiographic images of various of the human body, both pediatrics and adults, in a clinical environment.
The LaVid FMTS System is not intended for mammography, interventional, or fluoroscopy use.
Device Description
The LaVid FMTS System is a stationery X-ray system intended for obtaining radiographic images of various of the human body, both pediatrics and adults, in a clinical environment.
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