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PowerLook Density Assessment V4.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211506
510(k) Type
Traditional
Applicant
iCAD, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/12/2021
Days to Decision
59 days
Submission Type
Summary

PowerLook Density Assessment V4.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211506
510(k) Type
Traditional
Applicant
iCAD, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/12/2021
Days to Decision
59 days
Submission Type
Summary