Last synced on 22 September 2023 at 11:04 pm

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201382
510(k) Type
Abbreviated
Applicant
de Gotzen S.r.l.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
11/18/2020
Days to Decision
176 days
Submission Type
Summary

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201382
510(k) Type
Abbreviated
Applicant
de Gotzen S.r.l.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
11/18/2020
Days to Decision
176 days
Submission Type
Summary