Device Dossier
Ultrasound system, imaging, general-purpose
Device Dossier for Ultrasound system, imaging, general-purpose (Ultrasound system, imaging, general-purpose, Class IIa, sponsor Mindray Medical). ARTG…
- GMDN category: Ultrasound system, imaging, general-purpose
Intended purpose
Intended purpose It is intended for clinical ultrasound diagnosis and examination. •Indication for use It is intended for use in gynecology, obstetrics, abdominal,intra-operative, pediatric, small organ, cephalic, musculo-skeletal, cardiac,vascular, urology, nerve,thoracic/pleural,laparoscopic, and ophthalmic exams. •Intended users Intended users include doctor, nurse, clinical technologist,radio technologist and ultrasonographer proficient in medicine knowledge. •Intended patient population The diagnostic ultrasound system is applicable for adults,pregnant women, pediatric patients and neonates. •Intended medical conditions 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.