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RTVue XR OCT Avanti with AngioVue Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153080
510(k) Type
Traditional
Applicant
OPTOVUE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2016
Days to Decision
111 days
Submission Type
Summary

RTVue XR OCT Avanti with AngioVue Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153080
510(k) Type
Traditional
Applicant
OPTOVUE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2016
Days to Decision
111 days
Submission Type
Summary