GE Venue Ultrasound System
- 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
- Risk class
- Class B
- Registrant / registration holder
- GE HEALTHCARE PTE. LTD.
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).
- 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
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.