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Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223491
510(k) Type
Traditional
Applicant
GE Medical Systems, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/25/2023
Days to Decision
185 days
Submission Type
Summary

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223491
510(k) Type
Traditional
Applicant
GE Medical Systems, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/25/2023
Days to Decision
185 days
Submission Type
Summary