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DX-D Imaging Package with XD Detectors

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211790
510(k) Type
Traditional
Applicant
Agfa N.V.
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
7/30/2021
Days to Decision
50 days
Submission Type
Summary

DX-D Imaging Package with XD Detectors

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211790
510(k) Type
Traditional
Applicant
Agfa N.V.
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
7/30/2021
Days to Decision
50 days
Submission Type
Summary