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510(k) Data Aggregation
K Number
K250970Device Name
Marie
Manufacturer
Leo Cancer Care
Date Cleared
2025-07-25
(116 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Leo Cancer Care
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K231612Device Name
Eve Patient Positioner System
Manufacturer
Leo Cancer Care
Date Cleared
2024-05-07
(340 days)
Product Code
JAI
Regulation Number
892.5770Why did this record match?
Applicant Name (Manufacturer) :
Leo Cancer Care
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.
Device Description
The Leo Cancer Care (LCC) Patient Positioning Subsystem (EVE) is designed to deliver precise positioning of a patient when combined with an external Beam Therapy device, to provide the intended treatment therapy prescribed for patients requiring radiation treatments.
The Patient Positioning System has 6 degrees of freedom to provide full alignment capability for a patient treatment session, with the patient being located in an upright position. The Eve Patient Positioning Subsystem is held in a static position for the duration of the external Beam Therapy System radiation exposure. After the beam delivery has been completed, the patient positiong subsystem is then aligned to the next patient position required by the treatment system and the process repeated for the required series of different beam placements to achieve the full prescribed treatment delivery for the patient.
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