Singapore HSA registration DE0016899
GE Brivo NM 615
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90221200
Registration information
- Registration Number
- DE0016899
- Registration Date
- March 06, 2015
- Retention Due Date
- March 05, 2026
Product description
The system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in 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, planning, guiding, and monitoring therapy. The system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. Scanning modes include Planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and Tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include an assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
Product Owner
- Short Name
- GE Hualun Medical Systems Co Ltd
- Address
- No 1. Yong Chang North Road, Beijing, 100176, CHINA
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)
- R-MADE ARMREST FOAM ARMREST CONTOURED LEG REST IVY 3000M RWAVE TRIG+REC IVY 3000M RWAVE TRIG 17 LCD MILL ACQ MONITOR D670 STRAPS&PAD KIT Axial Head Holder NM DOLLIES D670 PALLET EXTENDER D630 IMAGING TABLE B615 NM 3/8" ACQ B615 Gantry B615 Detector B615 ACQ Package B615 Installation Kit B615 MEGP (1) w/Cart B615 LEHR (1) w/Cart B615 ELEGP COLL(1) W/CART B615 HEGP COLL(1) W/CART B615 PH COL(1) W/CART B615 Auto Body Contouring INFINIA BAR PHANTOM NM QA SOURCE HOLDER Xeleris 3 Workstation Xeleris 3 Essential Workstation
- Model Identifier(s)
- E8500NA E8500NB E8500NC H2505JW H2505JY H2506KK H3100NP H3100NW H3100PB H3100PG H3100PM H3100RC H3100TA H3100TB H3100TC H3100TD H3100TE H3100TF H3100TG H3100TH H3100TJ H3100TM H3602MS H3602SL H3901KE H3901TM
About this record
Access comprehensive regulatory information for GE Brivo NM 615 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016899 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on March 06, 2015.
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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