Singapore HSA registration DE0019294
GE Discovery™ MI Digital Ready
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0019294
- Registration Date
- June 02, 2017
- Change Notification Approval Date
- December 12, 2019
- Retention Due Date
- June 01, 2025
Product description
The system is intended for head and whole body attenuation corrected PET imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images, and to be used by trained healthcare professionals for imaging the distribution of radiopharmaceuticals in the body for assessment of metabolic (molecular) and physiologic functions in patients of all ages. It can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. It can assist in radiotherapy planning and can be used as a stand-alone head and whole body multi-slice CT diagnostic imaging system. The Lung Cancer Screening Option is indicated for using low-dose CT for lung cancer screening, which must be performed within the established inclusion criteria of programs/protocols that have been approved and published by a governmental body or professional medical society.
Product Owner
- Short Name
- GE Medical Systems LLC
- Address
- 3000 N. Grandview Blvd., Waukesha, WI 53188, USA, UNITED STATES
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)
- Respiratory Gating for Scanners Discovery MI Digital Ready Discovery MI Digital Ready Discovery MI Digital Ready Discovery MI Digital Ready Discovery MI Digital Ready Discovery MI Digital Ready
- Model Identifier(s)
- E8819KX S3200A S3200EL S3200ES S3200EX S3200MB S9130AH
About this record
Access comprehensive regulatory information for GE Discovery™ MI Digital Ready in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019294 and owned by GE Medical Systems LLC. The device was registered on June 02, 2017.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C