Device Dossier
ultrasound system - Ultrasound system, imaging, general-purpose
Device Dossier for ultrasound system - Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor…
- GMDN category: Ultrasound system, imaging, general-purpose
Intended purpose
It is intended for clinical ultrasound diagnosis and examination. It is intended for use in Abdominal, Gynecology, Obstetrics, Pediatric, Cardiac, Small Organ, Musculo-skeletal, Vascular, Nerve, Urology, Intra-operative, Cephalic, Ophthalmic, and Thoracic/Pleural exams. Intended users include doctor, nurse, clinical technologist, radio technologist and ultrasonographer proficient in medicine knowledge. The diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. Intended medical conditions are hospital (e.g., imaging laboratory, emergency room, patient bedside, and operating room), medical clinic, physician’s office or an imaging center