GE Vivid S5/S6 Diagnostic Ultrasound System - HSA Registration DE0009510
Access comprehensive regulatory information for GE Vivid S5/S6 Diagnostic Ultrasound 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 DE0009510 and owned by GE Medical Systems Israel. The device was registered on August 15, 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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HSA Official Data
CLASS B
DE0009510
GE Vivid S5/S6 Diagnostic Ultrasound System
HSA Registration Number: DE0009510
Product Description
The Vivid S5/Vivid S6 ultrasound unit is intended for the following applications: • Abdominal • Cardiac • Musculoskeletal including Superficial • Small Organ • Pediatric • OB/Gyn • Fetal Heart • Transesophageal • Peripheral Vascular • Neonatal Cephalic • Adult Cephalic • Intraoperative
Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181200
Registration Information
Registration Number
DE0009510
Registration Date
August 15, 2012
Change Notification Approval Date
April 28, 2016
Retention Due Date
August 14, 2025
Product Owner
Short Name
GE Medical Systems
Address
4 Etgar Street, Tirat Carmel 39120, 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)
e8Cs Biopsy Kit, single angle, disposable
GE M4S/3S Probe Sterile Multi-Angle Biopsy Starter Kit
Country specific kit
8L-RS Biopsy Kit
4C-RS Biopsy Kit
5S-RS
3S - RS
Curved Array (Convex) Transducer
Software Option
7S - RS
10S -RS
Software Option
4C-RS
e8C-RS
8C-RS
Printer
8L-RS
i12L-RS
Hardware Option (memory addition)
12L-RS
12L-RS Biopsy Kit
9L-RS
M4S-RS
Phased Array Sector Transducer
Rear Tray for auxillary items
Foot Switch
12S-RS
TEE Probe Adaptor for 6T-RS/9T-RS
Respiration Trace
Ext ECG Cable
Tissue Velocity Imaging and Tissue Tracking
TSI
ATO/ASO
Anatomical M Mode
Stress Echo
Smart Stress
IMT
B-Flow/BFI
LOGIQView
OB Application Module
TEE Probe Interface Module
LVO Contrast
Vascular/Abdominal Contrast
DICOM Network Connectivity
DICOM Print
DICOM Modality Work List
MPEGVue
eVue
Virtual Printer
Professional InkJet Printer
Digital B&W Video Printer Vivid S6
Digital Color Video Printer
USB Flash Card
MOD
6S-RS
Smart Depth
Vivid 3_4 Database Import (only for new systems with empty database)
Rear Tray
Wireless Network Interface
Digital B&W Video Printer Vivid S5
Uninterruptible Power Supply
V Module (AMM, ATO/ASO, IMT, MPEGvue, DICOM)
S Module (AMM, ATO/ASO, OB, MPEGvue)
CS Module (AMM, ATO/ASO, OB, MPEGvue, Stress)
Pediatric ECG adapter European standard
Pediatric ECG adapter US standard
VS5 BT10 CV SYST 220-240V
VS5 BT10 CV SYST 100-120V
VS6 BT10 CV SYST 220-240V
VS6 BT10 CV SYST 100-120V
SI/SRI
QA
AFI
AutoEF
Virtual Convex
USB Export
VS5/6 English Upgr BT10
VS5/6 BT10 UK (240V) Reg Sup & Lang kit
17" Monitor upgrade (no field upgrade- only available with new systems from Haifa)
Phased Array Sector Transducer
Plastic Covers for system for OR
Software Option
Software Option
Respiration Adapter
Pediatric ECG adapter and cables European standard
Hardware Option (memory addition)
Pediatric ECG adapter and cables US standard
Foot Switch
3Sc-RS
Phased Array Sector Transducer
Software Option
Software Option
Software Option
Software Option
Basic VS5 BT11 system WITH 15'' screen
Basic VS5 BT11 system WITH 17'' screen
Basic VS6 BT11 system
SW upgrade to Vivid S5/S6 from BT11 to BT12
SW upgrade to Vivid S5/S6 from BT11 to BT12
Country specific kit
TEE Clip-On Bite Guard Adult
TEE Clip-On Bite Guard Adult OR
Adult TEE Scanhead Protection Cover
6T (must have TEE Probe Interface Module)
9T (must have TEE Probe Interface Module)
TEE Conventional Bite Guard Pediatric
TEE Conventional Bite Guard Adult
6T - RS (must have TEE Probe Interface Module)
9T - RS (must have TEE Probe Interface Module)
Pediatric TEE Scanhead Protection Cover
TEE Cleaning and Storing system
TEE Storage Rack
6Tc-RS (must have TEE Probe Interface Module)
Software Option
P2D
P6D
Software Option
9L-RS Biopsy Kit
Model Identifier(s)
E8385MJ
E8385MZ
E8385MZ
E8385N
E8385NA
H4000PC
H4000PD
H4000PD
H4000PE
H4000PE
H4000PF
H4000PF
H4000SR
H40402LN
H40402LS
H40402LS
H40402LT
H40402LW
H40402LW
H40402LY
H40432LC
H40442LL
H40452LH
H40452LH
H41642LS
H41642LS
H44901AB
H45021KP
H45021LL
H45021LL
H45021LP
H45021LR
H45021LS
H45021LT
H45021LW
H45021LY
H45021LZ
H45021M
H45021MB
H45021MC
H45021MD
H45021ME
H45021MF
H45021MK
H45021ML
H45021MM
H45021MN
H45021MP
H45021MY
H45021NA
H45021NB
H45021NC
H45021NF
H45021NG
H45021RP
H45021SD
H45021SE
H45021SH
H45021TM
H45021TR
H45021TY
H45021WC
H45021WD
H45021WE
H45031BE
H45031BF
H45031DX
H45031DZ
H45031EB
H45031EC
H45031ED
H45031EE
H45031EF
H45031EG
H45031EH
H45031GX
H45031KK
H45031NM
H45031RD
H45031RP
H45031RW
H45031SB
H45031SC
H45031TE
H45031TF
H45031TJ
H45041CT
H45041CW
H45041DL
H45041DM
H45041DP
H45041EU
H45041EW
H45041EX
H45041FN
H45041FR
H45041FT
H45041FX
H45041JW
H45041MU
H45511EE
H45521CB
H45521CK
H45521DX
H45521DY
H45521JG
H45521JH
H45531MZ
H45531YM
H45541RN
H45551NK
H45551NM
H45551ZE
H4830JE
H4830JE
H4830JG
H4830JG
H4906BK