Rotograph Evo 3D
FDA 510(k) K111152 · Villa Sistemi Medicali S.P.A.
510(k) numberK111152
Submission
- Device name
- Rotograph Evo 3D
- Applicant
- Villa Sistemi Medicali S.P.A.
Buccinasco, IT - Received
- April 25, 2011
- Decision date
- July 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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More from Dental Imaging Technologies Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K180601 | Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark…OAS · Abbreviated | 11/02/2018SE |
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark…MUH · Abbreviated | 07/06/2017SE |
| K130109 | Endograph DCEHD · Abbreviated | 08/01/2013SE |
| K090749 | Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191EHD · Abbreviated | 05/18/2009SE |
| K080859 | DRF 4343JAA · Traditional | 06/04/2008SE |
| K050190 | ApolloKXJ · Abbreviated | 03/25/2005SE |
| K030634 | Endos DCEHD · Abbreviated | 07/21/2003SE |
| K030185 | Endos Ac/AcpEHD · Abbreviated | 03/11/2003SE |
| K002432 | Strato XEHD · Traditional | 09/01/2000SE |
| K000412 | Vision R/F Tilting TableIXR · Traditional | 04/24/2000SE |
Questions and answers
When was Rotograph Evo 3D cleared by the FDA?
Rotograph Evo 3D (K111152) received a 510(k) decision of Substantially Equivalent on July 22, 2011, 88 days after the submission was received.
What is the product code of K111152?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.