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ProFound AI Software V3.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203822
510(k) Type
Special
Applicant
iCAD Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/12/2021
Days to Decision
73 days
Submission Type
Summary

ProFound AI Software V3.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203822
510(k) Type
Special
Applicant
iCAD Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/12/2021
Days to Decision
73 days
Submission Type
Summary