Last updated: 27 May, 2026
Regulatory information
Product information
RBfracture™ is a Software as a Medical Device (SaMD) developed by Radiobotics ApS. It is intended exclusively for use by healthcare professionals and is not available for purchase by the general public.
Intended purpose:
RBfracture™ is a computer-assisted detection and diagnosis software device intended to assist healthcare professionals in reviewing trauma skeletal radiographs. It is not intended to replace clinical judgment or serve as the sole basis for diagnosis or treatment decisions.
Market authorisations
RBfracture™ has obtained regulatory authorisation in the following markets:
European Union
RBfracture™ is a Class IIa medical device, CE marked in accordance with EU MDR 2017/745. Conformity assessment has been carried out by TÜV SÜD (CE 0123).
Manufacturer
Radiobotics ApS, Esplanaden 8C, 1tv, 1263 Copenhagen, Denmark
Notified body
TÜV SÜD — CE 0123
Regulation
EU MDR 2017/745
Australia
RBfracture™ is included on the Australian Register of Therapeutic Goods (ARTG) as a Class IIb medical device.
ARTG number
484605
ARTG name
Emergo Asia Pacific Pty Ltd T/a Emergo Australia — X-ray image interpretive software
Australian sponsor
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Regulator
Therapeutic Goods Administration (TGA)
Brazil
RBfracture™ is registered with ANVISA, the Brazilian Health Regulatory Agency.
ANVISA registration
nº 81464750151
Manufacturer
Radiobotics ApS, Esplanaden 8C, 1tv, 1263 Copenhagen, Denmark
Detentor do Registro
Domo Salute Consultoria Regulatória Ltda, Cristóvão Colombo 2948/411, Porto Alegre, Brazil
Additional market authorisations
RBfracture™ has also obtained regulatory authorisation in the following markets. For details on availability and the applicable version in your region, please contact your Radiobotics representative.
For other geographies, product availability is subject to local regulatory clearance. Review our full geographic availability or contact us to inquire about availability in your region.
Consolidated regulatory statement
The following statement is included in all English-language marketing and promotional materials for RBfracture™.
RBfracture™ is intended exclusively for healthcare professionals and is not available for purchase by the general public. RBfracture is a Class IIa medical device, CE marked under EU MDR 2017/745 (CE 0123). RBfracture is included on the Australian Register of Therapeutic Goods (ARTG No. 484605) as “Emergo Asia Pacific Pty Ltd T/a Emergo Australia – X-ray image interpretive software”. Manufacturer: Radiobotics ApS, Esplanaden 8C, 1tv, 1263, Copenhagen, Denmark. Always follow the instructions for use.
Instructions for use
Instructions for use (IFU) for RBfracture™ are available electronically.
Incident reporting
Serious incidents must be reported directly to Radiobotics and the relevant competent authority.
Report to Radiobotics
[email protected] or +45 31 41 61 36
EU competent authority
Danish Medicines Agency (DKMA): dkma.dk
Australia
TGA: tga.gov.au
Brazil
ANVISA: gov.br/anvisa
Company information
Legal name
Radiobotics APS
CVR number
DK38973231
Registered address
Esplanaden 8C, 1tv, 1263 Copenhagen, Denmark
Regulatory inquiries
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