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TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230136
510(k) Type
Traditional
Applicant
CompAI Healthcare (Suzhou) Co.,ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/24/2023
Days to Decision
96 days
Submission Type
Summary

TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230136
510(k) Type
Traditional
Applicant
CompAI Healthcare (Suzhou) Co.,ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/24/2023
Days to Decision
96 days
Submission Type
Summary