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RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203681
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
4/9/2021
Days to Decision
113 days
Submission Type
Summary

RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203681
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
4/9/2021
Days to Decision
113 days
Submission Type
Summary