Singapore HSA registration DE0506974
GE MyoSPECT & MyoSPECT ES
Singapore·CLASS B·GE Medical Systems Israel, Functional Imaging·Registered June 17, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0506974
- Registration Date
- June 17, 2022
- Change Notification Approval Date
- November 01, 2024
- Retention Due Date
- June 16, 2025
Product description
Intended for Nuclear Medicine (NM) imaging procedures for detection of radioisotope tracer uptake in the patient body. Systems include a Nuclear Medicine system using tomographic scanning mode supported by various acquisition types. For use by appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of cardiac diseases and heart function for the evaluation of diseases, abnormalities, and disorders. The system output can also be used by the physician for planning, guiding, and monitoring. Performs (NM) imaging procedures for the detection of radioisotope tracer uptake in the patient body, using tomographic scanning of single or multi-isotopes with either single or multi energy peaks. Systems may include data and image processing to produce reconstructed trans-axial images. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation . Systems may be used for patients of all ages.
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)
- ECG Trigger MyoSPECT MyoSPECT ES
- Model Identifier(s)
- 5415574 H3912BC H3912BD
About this record
Access comprehensive regulatory information for GE MyoSPECT & MyoSPECT ES in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506974 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on June 17, 2022.
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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