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Qangio XA 3D

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182611
510(k) Type
Traditional
Applicant
Medis Medical Imaging Systems bv
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
5/30/2019
Days to Decision
251 days
Submission Type
Summary

Qangio XA 3D

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182611
510(k) Type
Traditional
Applicant
Medis Medical Imaging Systems bv
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
5/30/2019
Days to Decision
251 days
Submission Type
Summary