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510(k) Data Aggregation
K Number
K152994Device Name
Adaptivo
Manufacturer
Date Cleared
2016-02-03
(113 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Aurora Technology Development, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery: to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.
Device Description
Aurora Technology Development (ATD) Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It provides:
• pre-treatment plan delivery verification;
• the ability to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery;
• estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and
• an aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals.
ATD Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.
ATD Adaptivo has two (2) primary software modules: (1) the Adaptive Dose Recalculation (ADR) module; and (2) the In-vivo Dosimetry (IVD) module. These two (2) modules integrate seamlessly to provide the user full benefit of ATD Adaptivo.
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