K021372 is an FDA 510(k) clearance for the VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY. This device is classified as a Cephalometer (Class II - Special Controls, product code EAG).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on June 7, 2002, 38 days after receiving the submission on April 30, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1830.
| 510(k) Number | K021372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2002 |
| Decision Date | June 07, 2002 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EAG — Cephalometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1830 |