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DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161368
510(k) Type
Traditional
Applicant
Agfa HealthCare N.V.
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
9/22/2016
Days to Decision
128 days
Submission Type
Summary

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161368
510(k) Type
Traditional
Applicant
Agfa HealthCare N.V.
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
9/22/2016
Days to Decision
128 days
Submission Type
Summary