Body-orifice ultrasound imaging system transducer cover, image-enhancement

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Disponibbli minn:

Meditron Pty Ltd

Klassi:

Class IIa

Manifatturat minn:

Civco Medical Instruments Co Inc DBA CIVCO and CIVCO Medical Solutions 102 First Street South, Kalona, IA, 52247 United States Of America

Żona terapewtika:

60633 - Body-orifice ultrasound imaging system transducer cover, image-enhancement

Indikazzjonijiet terapewtiċi:

A non-sterile sheath containing an extra-luminal pocket/balloon portion intended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging. This is a single-use device.

L-istatus ta 'awtorizzazzjoni:

A

Data ta 'l-awtorizzazzjoni:

2013-10-01