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510(k) Data Aggregation
K Number
K121929Device Name
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
Manufacturer
Date Cleared
2013-01-17
(199 days)
Regulation Number
880.6775Why did this record match?
Applicant Name (Manufacturer) :
DIACOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.
Device Description
The Zephyr "x-series" Patient Positioning and Transfer System functions as an accessory to support a patient and positioning devices during imaging and radiation therapy procedures, and other procedures requiring the transfer of a patient. The Zephyr "x-series" Patient Positioning and Transfer System utilizes forced air as a low-friction bearing to transfer patients from one flat surface to another, eliminating the need to manually lift the patient.
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K Number
K050888Device Name
INTEGRA IMMOBILIZATION SYSTEM
Manufacturer
Date Cleared
2005-05-23
(46 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
DIACOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To enable head and neck immobilization for patient placement during radiation therapy planning and treatment.
Device Description
The Integra Immobilization System consists of three device options which may be used as the patient simulation and treatment circumstances indicate. All three options of the System utilize the same thermoplastic, all three are designed with high strength carbon fiber, with foam core to provide a strong but light weight support base and all three provide head, neck and shoulder immobilization for patients undergoing simulation or radiation therapy using the exact same attachment of the thermoplastic to the carbon fiber board.
The "Integra ce Extension" option to the Varian Exact Couch provides a means to attach the extension securely to the end of the Exact Couch utilizing Varian's end of table design. The board provides rigid support to the head and shoulders by means of its carbon fiber and foam core construction.
The "Integra ci Insert" option to the Varian Exact Couch provides the means to provide head, neck and shoulder immobilization on a CT Scanner couch or a Varian Exact Treatment Table. This insert fits into a mating recess in the CT table overlay or a similar insert space in the Exact Treatment Table.
The "Integra co Cantilever Board" option provides head, neck and shoulder immobilization as part of a stand alone carbon fiber and foam core board. The board is constructed utilizing carbon fiber surfaces with a foam interior. The result is an extremely stong but light weight board. The overall design of the board provides comfortable patient support and a means to index the board to the table or overlay that it rests upon.
The Integra Immobilization System utilizes the method of head, neck and shoulder fixation that is also commonly found in radiation therapy departments and has been repeatedly shown to be safe and effective in immobilizing the head, neck and shoulders. The thermoplastic from Orfit is heated in a water bath to a temperature that makes the thermoplastic moldable. The material is removed from the bath, dried and placed over the patients head, neck and shoulders. It is stretched over the head, neck and shoulders, molded to conform to the patients head, neck and shoulder contour and attached to the support board in such a way that the patient is firmly held in place and yet can be released from the position very quickly if needed. As the thermoplastic cools, it hardens and thus permanently maintains the patient contour for repeated identical immobilizations required during a course of treatment.
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