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510(k) Data Aggregation
K Number
K141743Device Name
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
Manufacturer
Date Cleared
2014-10-03
(95 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
RADIOLOGY SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for use by qualified medical personnel. (Not for mammography)
Device Description
This is a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. No routine user calibration or generator connection is required. AED and ACC are standard features. AED is automatic exposure detection. No synchronization connection to the generator is required. ACC is Automatic Calibration Control. Calibration values are automatically loaded at power-up. The TFT is inherently linear, and all that is necessary is to set a Start (Dark) and Stop (Bright) value to define the dynamic range you want to operate in. It is completely independent of the x-ray source. That is why this can be done at the factory. MECHANICAL: FITS IN THE BUCKY TRAY WITHOUT MODIFICATION... Ultra-Light Cassette Sized Detector easily moves from table top to wall to stretcher with ease. The system is compatible with CPI CMP 200 and Sedecal SHF series generators.
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K Number
K132294Device Name
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
Manufacturer
Date Cleared
2013-11-12
(112 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
RADIOLOGY SOLUTIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
Device Description
This is a complete stationary diagnostic x-ray system employing a digital x-ray panel coupled with image acquisition software. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in four different power ratings. All components are either 510(k) exempt or previously cleared. The only difference between the two models is the configuration of the tube stand. Galaxy has a straight arm and the Galaxy+ Plus is in a U-Arm configuration. Generators are available in 40-50-65-or 80 kW (High Frequency) models.
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