Submission Details
| 510(k) Number | K991310 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 16, 1999 |
| Decision Date | June 18, 1999 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
EXPLOR-X 70
Jun 1999
Decision
63d
Days
Class 2
Risk
About This 510(k) Submission
K991310 is an FDA 510(k) clearance for the EXPLOR-X 70, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Villa Sistemi Medicali S.P.A. (Wheeling, US). The FDA issued a Cleared decision on June 18, 1999, 63 days after receiving the submission on April 16, 1999. 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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