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Annalise Enterprise CXR Triage Trauma

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222268
510(k) Type
Traditional
Applicant
Annalise-AI Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/28/2023
Days to Decision
243 days
Submission Type
Summary

Annalise Enterprise CXR Triage Trauma

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222268
510(k) Type
Traditional
Applicant
Annalise-AI Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/28/2023
Days to Decision
243 days
Submission Type
Summary