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Radiance

GMV SOLUCIONES GLOBALES INTERNET SA · Model 5 · UDI-DI 08436567540024

MUJ

510(k) clearances

804

Adverse events (11 deaths)

267

Recalls

Facilities

Description

Radiance V5 is a software system intended for treatment planning and analysis of radiation therapy administered with devicessuitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dosedistributions expected during the proposed treatment, and may be used to administer treatments after review and approval by theintended user. The system functionality can be configured based on use

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.