HSA · registration DE0510690GE Vivid iq Ultrasound System
- Registration number
- DE0510690
- Model name
- 8C-RS; 6S-RS; 12S-RS; 3SC-RS; 4C-RS; 12L-RS; 9L-RS; C1-5-RS; L8-18i-RS; ML6-15-RS; E8Cs-RS; M5Sc-RS; 10T-D; L4-20t-RS; Needle Guide; Biopsy Starter Kit; Biopsy Starter Kit; Biopsy Starter Kit; Biopsy Starter Kit; L4-20t Verza biopsy starter kit; Biopsy Starter kit; Biopsy Starter Kit; Biopsy Starter Kit; 6Tc-RS; 6VT-D; 9T-RS; P2D; Vivid iq
- Model identifier
- 2354973; 47236956; 47237175; 47237516; 5125386; 5141337; 5212630; 5384874; 5393197; 5428942; 5641682; 5718483; 5772436; 5843289; E8385MJ; E8385NA; H40432LC; H40432LE; H40432LJ; H45201BLF; H45561FC; H46222LC; H4906BK; KN100106; KN100120; KN100122 01; TE100024; Vivid iq v208
- Registration date
- May 07, 2025
- Risk class
- Class B
- Product owner
- GE Medical Systems (China) Co., Ltd.
- Registrant / registration holder
- GE HEALTHCARE TECHNOLOGIES PACIFIC PRIVATE LIMITED
The Vivid iq is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy, Vascular access), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal.
- Product owner address
- No. 19 Changjiang Road, Wuxi National Hi-Tech Dev. Zone, 214028 Jiangsu, China
- 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.