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GE SIGNA™ PET/MR System - HSA Registration DE0017213

Access comprehensive regulatory information for GE SIGNA™ PET/MR System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017213 and owned by GE Medical Systems LLC. The device was registered on June 08, 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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CLASS B
DE0017213
GE SIGNA™ PET/MR System
HSA Registration Number: DE0017213
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Product Description

The SIGNA PET/MR System combines magnetic resonance diagnostic devices (MRDD) and Positron Emissions Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181300
Registration Information
Registration Number
DE0017213
Registration Date
June 08, 2015
Change Notification Approval Date
August 18, 2017
Retention Due Date
June 07, 2025
Product Owner
Short Name
GE Medical
Address
3000 North Grandview Blvd, Waukesha, WI 53188, 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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
700 VA PARTIAL UPS-MR OXYGEN MONITOR FOR MR ROOM Remote Magnet Rundown Unit SAGE 7 0 Spectroscopy Analysis by GE, Version 7 PROBE-PRESS PROBE-PRESS AND STEAM VOXEL PROBE 2DCSI PROBE 3DCSI 3.0T MNS Carbon T/R Switch (optional) 3.0T MNS Phosphorous T/R Switch (31P Switch is required with MNS) 3.0T Calibration Kit ENGLISH KEYBRD KIT BLK BrainWave Real Time BrainWave Post Acquisition (requires BrainWave Real Time) BrainWave Fusion on Operator Console (requires BrainWave PA, DTI and FiberTrak) fMRI BrainWave Hardware (requires BrainWave Real Time) Upgrading BrainWave Lite to include PC LCD MONITOR STARMAP ACQUISITION (MFGRE 2D) SWAN MR Echo TRICKS FGRE-ET 2D Myocardial Delayed Enhancement and Blackblood SSFSE CARDIAC 3D MDE CARDIAC TAGGING 3D CARDIAC NAVIGATOR IDEAL & Flex DIFFUSION TENSOR FIBERTRAK VIBRANT BREASE Cartigram T2 Cartilage Mapping Flow Analysis 4.0 on Console BRAIN STAT WITH AIF Needle-Free Exam 0 Liver (contains IDEAL IQ and MR Touch, requires IDEAL, M7000CP) GEM Table Breast Array GEM Table Breast Array – no biopsy CADstream 5.2 Upgrade from 4.1.3 on MR console and AW (Software only, requires HP hardware) Ceiling Height Kit for Wide Bore Systems CUBE WITH T1 PROPELLER 3.0 eDWI – Enhanced Diffusion Weighted Imaging 3D ASL INHANCE 3D DELTA FLOW 3D HEART FGRE Time Course READY BRAIN CADstream 5.2 Upgrade from 4.1.3 on MR console (Software only, requires HP hardware) CADstream 5.2 on MR console and AW (contains hardware & software) CADstream 5.2 Upgrade from 3x, 4.0, 4.1 on MR console and AW (contains hardware & software) INHANCE SUITE Service IP Protect Disabler MAVRIC SL IDEAL IQ 16ch GEM Flex Suite, Premium 16ch GEM Flex Suite, Standard 16ch Small Flex Coil with Interface VIBROACOUSTIC DAMPING KIT Pre-Install Collector Gradient Cable Collector Configuration A Gradient Cable Collector Configuration B Gradient Cable Collector Configuration C MR Touch Cable Concealment Kit Silent Neuro Exam 3.0T FOCUS Body Navigators BrainWave Advanced Visualization BrainWave Advanced DTI Tracking BrainWave Structured Reporting 3D PROMO T2 and T2 FLAIR 3.0T Silent MRA System Cable Collector Configuration A System Cable Collector Configuration B System Cable Collector Configuration C 3.0T LAA 3.0T HNU 3.0T UAA PET/MR 3.0T Equipment Room Collector PET/MR 3.0T Site Collector PET/MR 3.0T Magnet Assembly PET/MR 3.0T Scan Room Collector PET/MR 3.0T Patient Table PET/MR Main Disconnect Panel PET/MR Cable Collector Configuration A PET/MR Cable Collector Configuration B PET/MR Cable Collector Configuration C PETMR PET 700VA UPS For PARC PETMR 8Ch HiRes Brain Array (Receive Only) 3.0T PET/MR CMA PET/MR 3.0T Insert with Detectors PET/MR 3.0T Coil Suite with CMA, HNU, UAA & LAA MNS Upgrade for sites with 8kW Amp MNS Package-8kW Amp PET Base PET Gating PET ACQC PET VUE Point HD PET List Mode PET Performance Tools PET Q.Core +1 PET Volume Viewer PET VUE Point FX PET SharpIR PET Q.Core +2 PET Q.Static MR Seismic Sub Contract
Model Identifier(s)
E4504FM M1060KM M1060KN M3090MC M3333WG M3333WH M3333WJ M3333WK M3334WF M3334WG M3335CD M3335JZ M3335KR M3335KS M3335KT M3335MJ M3335MK M3335MT M3340AE M3340AG M7000CA M7000CB M7000CD M7000CF M7000CG M7000CH M7000CL M7000CP M7000CT M7000CW M7000EG M7000EH M7000EJ M7000EZ M7000FC M7000FN M7000GF M7000GG M7000GJ M7000GM M7000HZ M7000JA M7000JB M7000JC M7000JD M7000JF M7000JG M7000JH M7000JJ M7000JK M7000JL M7000JS M7000JT M7000PF M7000PG M7000SK M7000SL M7000SM M7000VM M7000WM M7000YS M7000YT M7000YW M7000ZE M7000ZT M7001SC M7001SE M7001SF M7001SH M7001SJ M7001SK M7001SL M7001SN M7004ZF M7004ZG M7004ZH M8000CA M8000CB M8000CC M8000PA M8000PB M8000PC M8000PD M8000PE M8000PH M8000PK M8000PL M8000PM M8000PR M8000RA M8000RB M8000RF M8000RG M8000RH M8000RJ M8000SA M8000SB M8000SC M8000SD M8000SE M8000SF M8000SG M8000SH M8000SJ M8000SK M8000SL M8000SM R4390JA