Last synced on 6 December 2024 at 11:05 pm

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