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Focus HD 43 Detector

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213529
510(k) Type
Special
Applicant
iRay Technology Taicang Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/29/2022
Days to Decision
145 days
Submission Type
Summary

Focus HD 43 Detector

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213529
510(k) Type
Special
Applicant
iRay Technology Taicang Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/29/2022
Days to Decision
145 days
Submission Type
Summary