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HSA · registration DE0510439

GE Venue Ultrasound System

SingaporeRadiology / ImagingClass BGE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Official record identity
Registration number
DE0510439
Model name
8C-RS; 6S-RS; 12S-RS; 3Sc-RS; 12L-RS; 9L-RS; E8C-RS; C1-5-RS; L8-18i-RS; ML6-15-RS; L4-12t-RS; L10-22-RS; L12n-RS; M5Sc-RS; C2-9-RS; L4-20t-RS; Needle Guide; Biopsy Starter Kit; Biopsy Starter Kit; ECG Kit W/ IEC Cable; Verza Guidance System; Biopsy Starter Kit; Biopsy Starter kit; Biopsy Starter Kit; Biopsy Starter Kit; Biopsy Starter Kit; 6Tc-RS; Venue; Venue; Venue
Model identifier
2354973; 47236956; 47237175; 47237516; 5141337; 5212630; 5318734; 5384874; 5393197; 5428942; 5433596; 5441887; 5505759; 5718483; 5761811; 5843289; E8385MJ; H40432LC; H40432LE; H45124VEEGG; H45201BLF; H45281BL; H45561FC; H46222LC; H48392LL; H48392LT; KN100106; Venue R5; Venue R5 UPG; Venue R5W
Registration date
March 07, 2025
Source update date
May 11, 2026
Classification
Risk class
Class B
Official value: CLASS B
Published category
Radiology / Imaging
Published parties
Registrant / registration holder
GE HEALTHCARE PTE. LTD.
Official description

For use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education/training. Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN&Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional&superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).

Additional source fields
Product owner address
3200 N Grandview Blvd, Waukesha, WI 53188, United States
Registrant address
11 NORTH BUONA VISTA DRIVE, #11-07, THE METROPOLIS, Singapore 138589
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.