U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Densitometer, bone - Product Code KGI
원인
The frax adjusted for tbs values are not correct when: the frax feature is activated in tbs insight; and tbs has been computed from a spine scan where some vertebrae were excluded.
조치
Medimaps sent an Urgent Field Safety Notice letter dated October 3, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken.
Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.
제품 설명
TBS iNsight Version v.3.0.1 || Product Usage: || TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.