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Plan AI

SUN NUCLEAR CORP. · Model 1057 · UDI-DI 05060608881574

MUJ Prescription

510(k) clearances

807

Adverse events (11 deaths)

267

Recalls

Facilities

Description

Plan AI is used to configure and review radiotherapy treatment plans for a patient with malignant or benign disease in the head and neck, thoracic, abdominal, and pelvic regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists).

Recalls

Date	Firm	Reason
2026-05-20	RAYSEARCH LABORATORIES AB	Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,
2026-05-20	RAYSEARCH LABORATORIES AB	Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session,
2025-12-12	Elekta, Inc.	Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea
2025-12-12	Elekta, Inc.	Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea
2025-11-28	RAYSEARCH LABORATORIES AB	Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto
2025-11-28	RAYSEARCH LABORATORIES AB	Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto
2025-11-28	RAYSEARCH LABORATORIES AB	Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto
2025-11-28	RAYSEARCH LABORATORIES AB	Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto
2025-11-28	RAYSEARCH LABORATORIES AB	Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto
2025-11-28	RAYSEARCH LABORATORIES AB	Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.