FDA-Device2023-12-20Class II

SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System

Bebig Isotopentechnik Gmbh
Hazard

Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.

Sold states
US: MD OUS: Germany
Affected count
2 software licenses in US, 255 software licenses in OUS
Manufactured in
Robert-Rossle-Str. 10, N/A, Berlin, N/A, Germany
Products
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0517-2024

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