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Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180601
510(k) Type
Abbreviated
Applicant
Villa Sistemi Medicali S.p.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
11/2/2018
Days to Decision
240 days
Submission Type
Summary

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180601
510(k) Type
Abbreviated
Applicant
Villa Sistemi Medicali S.p.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
11/2/2018
Days to Decision
240 days
Submission Type
Summary