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510(k) Data Aggregation
K Number
K013620Device Name
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
Manufacturer
MEDSTONE INTL., INC.
Date Cleared
2002-01-22
(78 days)
Product Code
IZF
Regulation Number
892.1740Why did this record match?
Applicant Name (Manufacturer) :
MEDSTONE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medstone, Radiographic Linear Tomography Option is designed as an optional additional device to the Medstone UroPro 2000 table, intended for use in general radiology. It is designed to enable the production of diagnostic radiologic images of a specific linear cross-sectional plane of the body, eliminating unwanted anatomy and detail by motion blurring of other planes.
This device is designed to provide and control the sweep speed and angle of a tomography function to enable the production of a properly imaged X-ray film to accomplish diagnostic imaging of a patient.
The table and tomography option are intended to be used by trained professionals, schooled in proper radiology procedures, techniques, positioning and safety.
Device Description
The Medstone, Radiographic Linear Tomography Option is designed as an 'add-on' optional device to enable the production of radiologic images of a specific linear cross-sectional plane of the body by blurring or eliminating detail from other planes. A high degree of emphasis for the design of this device was placed on error detection and reliability as well as usability and safety.
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K Number
K010900Device Name
STS-T LITHOTRIPTER, MODEL STS-T
Manufacturer
MEDSTONE INTL., INC.
Date Cleared
2001-04-05
(10 days)
Product Code
LNS
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
MEDSTONE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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