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510(k) Data Aggregation
K Number
K112969Device Name
AIR-BAG SYSTEM
Manufacturer
Date Cleared
2012-03-14
(161 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NIIGATA MECHATRONICS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of this Air-Bag System is to monitor patient's respiratory cycle and to fix the trunk of the body of patient during radiation therapy.
This Air-Bag System can properly press the abdomen and stabilize patient's positioning repeatability easily in continuous radiation therapy.
Device Description
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