HSA · registration DE0510129GE Voluson SWIFT ultrasound systems
- Registration number
- DE0510129
- Model name
- 12S-RS; 3Sc-RS; 4C-RS; 12L-RS; 9L-RS; C1-5-RS; IC9B-RS; Needle Guide; Biopsy Starter Kit; ECG -USB1; Biopsy Starter Kit; Biopsy Starter Kit; Biopsy Starter Kit; Needle Guide; Biopsy Starter Kit; RAB2-6-RS; RAB6-RS; IC9-RS; Needle Guide; Needle Guide; Needle Guide; RIC5-9A-RS; Biopsy Starter Kit; Voluson SWIFT; Voluson SWIFT+
- Model identifier
- 47237175; 47237516; 5125386; 5141337; 5212630; 5384874; 5835938; E8385MJ; E8385NA; ECG -USB1-EX; H40432LC; H40432LE; H46222LC; H48681GF; H48681ML; H48681WR; H48691LP; H48691PJ; H48691YW; H48691YX; H48691Z; H48701EJ; H4906BK; Voluson SWIFT; Voluson SWIFT+
- Registration date
- December 11, 2024
- Risk class
- Class B
- Product owner
- GE Ultrasound Korea, Ltd.
- Registrant / registration holder
- GE HEALTHCARE TECHNOLOGIES PACIFIC PRIVATE LIMITED
This system is intended for ultrasound evaluation in the following clinical application: Image Acquisition for diagnostic purposes including measurements on acquired images. The device may be used by qualified physicians, sonographers, and healthcare professionals that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Clinical applications include: Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal, Peripher vascular, Pediatrics, Cephalic, MSK, Breast and Small part.
- Product owner address
- 9, Sunhwan-ro, 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13204, Korea, South
- 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.