Derived label

Device software or design

Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: Incorrect source step size may occur in the software
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Nucletron BV