HSA · registration DE0510399GE Voluson Expert (18, 20, 22) Series Ultrasound Systems
- Registration number
- DE0510399
- Model name
- 6S-D; 11L-D; 9L-D; IC5-9-D; ML6-15-D; L8-18i-D; C2-9-D; C1-6-D; M5Sc-D; RM7C; eM6C G3; RIC10-D; RAB7-D; Needle Guide; Biopsy Starter Kit; Biopsy Starter Kit; Needle Guide; Needle Guide; Needle Guide; Biopsy Starter kit; Biopsy Starter Kit; RSP6-16-D; RIC5-9-D; RIC6-12-D; Needle Guide; RAB6-D; Biopsy Starter Kit; ECG ASSY W/ IEC CABLE; Biopsy Starter Kit; Biopsy Starter Kit; Biopsy Starter Kit; Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- Model identifier
- 47236955; 5176269; 5194432; 5194434; 5199103; 5336965; 5405253; 5418916; 5446812; 5790293; 5835134; 5845346; 5929364; E8385MJ; H40432LC; H40432LJ; H44901AW; H44901AX; H44901AY; H45561FC; H46701AD; H48651MR; H48651MS; H48651NA; H48681GF; H48681MG; H48681ML; H48711KX; H4906BK; H4913BA; H4913BB; Voluson Expert 18 BT25; Voluson Expert 20 BT25; Voluson Expert 22 BT25
- Registration date
- February 27, 2025
- Risk class
- Class B
- Product owner
- GE Healthcare Austria GmbH & Co OG
- Registrant / registration holder
- GE HEALTHCARE TECHNOLOGIES PACIFIC PRIVATE LIMITED
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
- Product owner address
- Tiefenbach 15, 4871 Zipf, Austria
- 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.