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cvi42 Auto Imaging Software Application

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213998
510(k) Type
Traditional
Applicant
Circle Cardiovascular Imaging Inc
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
7/28/2022
Days to Decision
219 days
Submission Type
Summary

cvi42 Auto Imaging Software Application

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213998
510(k) Type
Traditional
Applicant
Circle Cardiovascular Imaging Inc
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
7/28/2022
Days to Decision
219 days
Submission Type
Summary