Home › GMV SOLUCIONES GLOBALES INTERNET SA › radiance

radiance

GMV SOLUCIONES GLOBALES INTERNET SA · Model 3 · UDI-DI 08436567540000

MUJ Prescription

510(k) clearances

804

Adverse events (11 deaths)

267

Recalls

Facilities

Description

Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.