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3.0T GEM RT Open Array

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143389
510(k) Type
Traditional
Applicant
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/6/2015
Days to Decision
100 days
Submission Type
Summary

3.0T GEM RT Open Array

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143389
510(k) Type
Traditional
Applicant
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/6/2015
Days to Decision
100 days
Submission Type
Summary