Singapore HSA registration DE0502814
GE NM/CT 860 Imaging System
Singapore·CLASS C·GE Medical Systems Israel, Functional Imaging·Registered February 26, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0502814
- Registration Date
- February 26, 2019
- Change Notification Approval Date
- June 03, 2019
- Retention Due Date
- February 25, 2026
Product description
The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Computed Tomography applications. The GE NM/CT 860 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of 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; and planning, guiding, and monitoring therapy.
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 860 NM/CT 860
- Model Identifier(s)
- H2506KR H3908AH H3908AJ
About this record
Access comprehensive regulatory information for GE NM/CT 860 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 DE0502814 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on February 26, 2019.
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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