Last synced on 7 June 2024 at 11:04 pm

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223288
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/21/2023
Days to Decision
269 days
Submission Type
Summary

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223288
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/21/2023
Days to Decision
269 days
Submission Type
Summary