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510(k) Data Aggregation
K Number
K203146Device Name
Akesis Galaxy RTi
Manufacturer
Akesis Inc
Date Cleared
2021-03-05
(135 days)
Product Code
IWB
Regulation Number
892.5750Why did this record match?
Applicant Name (Manufacturer) :
Akesis Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures for adults.
Device Description
The Akesis Galaxy RTi, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position. consists of a) The y-ray treatment unit, and b) interface to a stereotactic localization system, and c) kV x-ray positioning and verification system
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K Number
K200050Device Name
Akesis Galaxy RTx
Manufacturer
Akesis Inc
Date Cleared
2020-02-04
(25 days)
Product Code
IWB
Regulation Number
892.5750Why did this record match?
Applicant Name (Manufacturer) :
Akesis Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.
Device Description
The Akesis Galaxy RTx, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position.
The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient's head is immobilized in a headframe which has been fitted prior to the commencement of treatment. The entire system consists of a) the y-ray treatment unit, and b) the stereotactic localization system.
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K Number
K190844Device Name
Akesis Galaxy
Manufacturer
Akesis Inc
Date Cleared
2019-09-04
(156 days)
Product Code
IWB
Regulation Number
892.5750Why did this record match?
Applicant Name (Manufacturer) :
Akesis Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures
Device Description
The Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The v-ray treatment unit, and b) the stereotactic localization system.
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