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FractureDetect (FX)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193417
510(k) Type
Traditional
Applicant
Imagen Technologies, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/2020
Days to Decision
234 days
Submission Type
Summary

FractureDetect (FX)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193417
510(k) Type
Traditional
Applicant
Imagen Technologies, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/30/2020
Days to Decision
234 days
Submission Type
Summary