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GE EchoPAC PC software - HSA Registration DE0009488

Access comprehensive regulatory information for GE EchoPAC PC software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0009488 and owned by GE Vingmed Ultrasound AS. The device was registered on August 14, 2012.

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
DE0009488
GE EchoPAC PC software
HSA Registration Number: DE0009488
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Product Description

EchoPAC PC software is indicated for diagnostic review and analysis of ultrasound images acquired via B, M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0009488
Registration Date
August 14, 2012
Change Notification Approval Date
March 10, 2016
Retention Due Date
August 13, 2025
Product Owner
Short Name
GE Vingmed Ultrasound
Address
Strandpromenaden 45, N-3183 Horten, NORWAY
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)
EchoPAC BT'09 SWO Software upgrade Stereo Glasses for 3D visualization Spectacle Casing Anacrome 3D glasses Anacrome 3D glasses Clip-On Flips EchoPac PC BT'09 turnkey software upgrade EchoPAC PC BT09 SW-Only Basic Permanent license EchoPAC PC BT09 SW-Only Trial Assembly EchoPac PC BT’09 software upgrade External USB hard disk EchoPAC PC BT10 SW-Only Basic Permanent license EchoPAC PC BT10 SW-Only Trial Assembly EchoPAC PC BT12 SW-Only Basic Permanent license EchoPAC PC BT12 Plug-in EchoPAC PC BT12 SW-Only Trial Assembly EchoPAC PC Turnkey Upgrade from BT'09/BT'11 to BT12 EchoPAC PC SoftwareOnly Upgrade from BT'09/BT'11 to BT12 EchoPAC PC Turnkey to Software Only Conversion BT12 EchoPAC Plug-in BT12 Upgrade from BT'09/BT'11 Turnkey EchoPAC Plug-in BT12 Upgrade from BT'09/BT'11 Software Only EchoPAC Plug-in BT12 Upgrade from BT11 Plug-in 4D Package Advanced 4D Package Advanced QScan Imaging AFI Package IMT - Intermedia Thickness 2D Strain Auto 2D EF EchoPAC Share, max. 3 GE clients. EchoPAC DICOM Share Mitral Valve Assessment 4D LV Volume 4D RV Volume Vivid BT12 Raw Data Module EchoPAC BT13 SWO upgrade from BT'09, BT'11 or BT12 SWO EchoPAC TK to SWO Conversion BT13 EP BT13 TK PlugIn conv EP BT13 SWO PlugIn conv EchoPAC SoftwareOnly v201 EchoPAC Plug-in v201 VP EchoPAC Plug-in v201 Gen EchoPAC SWO v201 Start kit EchoPAC SWO v201 Repl. Kit EP PI v201 Gen Repl Kit EP PI v201 VP Repl Kit DICOM viewer on media 5-PACK EchoPAC Software Only 10-PACK EchoPAC Software Only 20-PACK EchoPAC Software Only 50-PACK EchoPAC Software Only Mitral Valve Assessment 4D LV Volume 4D RV Volume 5-PACK EchoPAC Plug-in VP 10-PACK EchoPAC Plug-in VP MVA TT upgrade for v201 LV TT upgrade for v201 RV TT upgrade for v201
Model Identifier(s)
H45551 SC H45551MH H45551MJ H45551MK H45551ML H45551PX H45551SA H45551SB H45551SC H45561BL H45561HY H45561JB H45561TK H45561TL H45561TN H45561TP H45561TR H45561TS H45561TW H45561TX H45561TY H45561TZ H45561WA H45561WB H45561WD H45561WE H45561WF H45561WG H45561WH H45561WJ H45561WK H45561WM H45561WP H45561YJ H45571MW H45571WR H45571WS H45571WT H45581BK H45581BM H45581BN H45581BP H45581BR H45581BS H45581BV H45581CC H45581LE H45581LF H45581LG H45581LK H45581LL H45581LM H45581LN H45581MC H45581MD H45581TN H45581TP H45581TR