Singapore HSA registration DE0508660
GE Omni Legend
Singapore·CLASS C·GE Medical Systems Israel, Functional Imaging·Registered November 14, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508660
- Registration Date
- November 14, 2023
- Retention Due Date
- November 13, 2025
Product description
The Omni Legend system is intended for CT attenuation corrected (CTAC), anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging. The Lung Cancer Screening Option for Qualified GE CT Systems is indicated for using low-dose CT for lung cancer screening. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society.
Product Owner
- Short Name
- GE Medical Systems Israel, Functional Imaging
- Address
- 4 Hayozma Street, Tirat Hacarmel, 30200, ISRAEL
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- Cardiac Trigger Monitor 7800 Omni Legend
- Model Identifier(s)
- 7800 Omni Legend
About this record
Access comprehensive regulatory information for GE Omni Legend in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508660 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on November 14, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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