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

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
10-11-2017

可用日期:

Meditron Pty Ltd

类:

Class IIa

厂商:

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

治疗领域:

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

疗效迹象:

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.

授权状态:

A

授权日期:

2013-10-01

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