Radiance v5

Organization name

GMV SOLUCIONES GLOBALES INERNET S.A.U.

SRN

ES-MF-000000685

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  Read carefully the User's Manual before using this software. The use of this product could suppose potential hazardous situations.
• CW011

  • Radiance should not be used with images of patients with metal artifacts or other high-density materials. The presence of this elements can affect the quality of images and compromise the accuracy of the calculations. // • Radiance should not be used with images with poor resolution or registration issues. Poor resolution or registration issues of the scan devices can affect the quality of input data and it can lead to errors in target delineation. // • Radiance should not be used with non-compatible LINACs. Radiance v5 is only compatible with INTRABEAM 700 and Mobetron, planning for other products may result in erroneous calculations. // • Radiance should not be used by persons without the necessary training and qualifications. After planning, it is responsibility of the specialists to interpret correctly the real anatomic situation according to their knowledge and experience, therefore all users must have knowledge of radiation therapy, be authorized by their national accreditation agencies, and possess all the necessary professional licenses. // While the RTPS itself isn’t contraindicated, the decision to use radiation therapy may be. For instance, if a patient has conditions that contraindicate radiation treatment (such as previous high-dose radiation to the same area, certain connective tissue diseases, or poor performance status), then planning radiation therapy—and by extension using an RTPS—is not appropriate.

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08436567540024

Basic UDI-DI

843656754RADIANCEA2

Reference / catalog number

Radiance v5

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

INTRAOPERATIVE RADIOTHERAPY TREATMENT PLANNING SYSTEM

Additional information URL

https://www.gmv.com/en-es/products/healthcare/intraplan-radiance

Clinical sizes

No clinical sizes registered for this device.

• Z11010401RADIOTHERAPY TREATMENT PLANNING SYSTEMS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification