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Treatment Planning System

Clinical treatment-planning software for radiotherapy workflows.

FDA 510(k) cleared · K182665

Overview

The Treatment Planning System (TPS) is clinical software designed to support radiotherapy workflows, enabling clinicians to define, optimize, and document treatment parameters prior to delivery. Software in this class is subject to IEC 62304 lifecycle requirements and must integrate tightly with device hardware and clinical data stores.

Role

Product and regulatory strategy for the TPS at Sensus Healthcare ensured that software development processes aligned with IEC 62304 requirements and that the system supported a defensible regulatory position.

Clearance

FDA 510(k) cleared (K182665).

Clinical SoftwareIEC 62304SQL