ROTOGRAPH EVO 3D
FDA 510(k) clearance K111152 · decided 2011-07-22
Clearance details
- K-number
- K111152
- Device name
- ROTOGRAPH EVO 3D
- Applicant
- Villa Sistemi Medicali S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-25
- Decision date
- 2011-07-22
- Days to decision
- 88 days
- Clearance type
- Abbreviated
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Buccinasco, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Villa Sistemi Rotograph EVO 3D X-ray recall (Z-0128-2016) | Villa Radiology Systems LLC | 2015-11-06 |