HSA · registration DE0509747Radiobotics RBfracture
SingaporeRadiology / ImagingClass BRadiobotics ApS
Official record identity
- Registration number
- DE0509747
- Model name
- RBfracture
- Model identifier
- RBfracture
- Registration date
- September 06, 2024
- Source update date
- February 20, 2026
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Radiobotics ApS
- Registrant / registration holder
- QUALTECH CONSULTING CORPORATION PTE. LTD.
Official description
RBfracture is a computer-assisted detection and diagnosis software device to assist healthcare professionals in reviewing trauma skeletal radiographs. The expected clinical benefit of RBfracture is to reduce the number of missed fractures impacting the health of individuals.
Additional source fields
- Product owner address
- Esplanaden 8C 1. tv, 1263 Copenhagen, Denmark
- Registrant address
- 111 NORTH BRIDGE ROAD, #21-01, PENINSULA PLAZA, Singapore 179098
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.