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510(k) Data Aggregation
K Number
K081218Device Name
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
Manufacturer
Date Cleared
2008-07-21
(82 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
IT-V MEDIZINTECHNIK, GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The function of the BellySTEP™ is for positioning of the lower abdomen of a patient during radiotherapy and diagnostics.
The function of the HeadSTEP™ is for fixation and (re)positioning of the head and neck area of the patient during radiotherapy and diagnostics.
The function of the BreastSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
The function of the ProSTEP™ is for positioning of hip and lower extremities of a patient for radiotherapy.
The function of the WingSTEP™ is for positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.
The function of the iCAST™ thermoplastic materials are for use in retaining and reproducing a patient's position during radiation therapy.
Device Description
BellySTEP™: The BellySTEP™ is made for the positioning of the lower abdomen of a patient. The BellySTEP™ Baseplate enables the use of Inter-changeable inserts. It is made of Polyethylene Foam and covered with artificial leather.
HeadSTEP™: The HeadSTEP™ iFRAME based immobilization system guarantees high precision and facile repositioning in routine cranial as well as head and neck immobilization.
BreastSTEP™: The BreastSTEP™ enable positioning, repositioning and high comfort in the routine breast and thorax fixation.
ProSTEP™: The ProSTEP™ was designed to improve the accuracy of the positioning of the hip and the lower extremities.
WingSTEP™: The WingSTEP™ enable positioning, repositioning and high comfort in the routine breast and thorax fixation.
iCAST™: The iCAST™ Thermoplastic is a non-sticky low temperature thermoplastic sheet material for the production of immobilization masks (head, head/neck) for patients undergoing radiation therapy treatment.
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