Submission Details
| 510(k) Number | K090749 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 2009 |
| Decision Date | May 18, 2009 |
| Days to Decision | 59 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Abbreviated
ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
May 2009
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K090749 is an FDA 510(k) clearance for the ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on May 18, 2009, 59 days after receiving the submission on March 20, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
Device Classification
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |
Manufacturer
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