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PowerLook Tomo Detection V2 Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182373
510(k) Type
Traditional
Applicant
iCAD Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2018
Days to Decision
97 days
Submission Type
Summary

PowerLook Tomo Detection V2 Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182373
510(k) Type
Traditional
Applicant
iCAD Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2018
Days to Decision
97 days
Submission Type
Summary