Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)— 510(k) K162190
Substantially EquivalentVilla Sistemi Medicali S.P.A.
FDA 510(k) clearance K162190 for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology), Substantially Equivalent on 2017-07-06. Applicant: Villa Sistemi Medicali S.P.A..
Clearance details
- Applicant
- Villa Sistemi Medicali S.P.A.
- Product code
- Code MUH
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Buccinasco, IT
Data sourced from openFDA. This site is unofficial and independent of the FDA.