Singapore HSA registration DE0504598
GE NM/CT 870 CZT Imaging System
Singapore·CLASS C·GE Medical Systems Israel, Functional Imaging·Registered June 12, 2020Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0504598
- Registration Date
- June 12, 2020
- Retention Due Date
- June 11, 2025
Product description
The NM/CT 870 CZT system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. 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, 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)
- Integrated ECG NM/CT 870 CZT
- Model Identifier(s)
- H2506KR H3906CV
About this record
Access comprehensive regulatory information for GE NM/CT 870 CZT Imaging System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504598 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on June 12, 2020.
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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