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510(k) Data Aggregation
K Number
K982446Device Name
DYNAMIC SHIELDING RADIATION TABLE
Manufacturer
Date Cleared
1998-09-29
(76 days)
Product Code
Regulation Number
892.5770Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN BIOPHYSICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To be used in treatment where whole body radiation therapy is indicated. The shielding tray reduces the radiation exposure to those organs, such as lungs, which are desired to be shielded.
Device Description
The Dynamic Radiation Table, is a PC-controlled table which permits total body radiation and incorporates a series of moving tables or trays - one for the patient to lie on, protective organ shields tray and an attenuating tray. It incorporates a number of features such as x-ray trays for verification of radiation dose, number of safety features and limit switches.
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