K013893 is an FDA 510(k) clearance for the SCANX. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on February 1, 2002, 70 days after receiving the submission on November 23, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K013893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2001 |
| Decision Date | February 01, 2002 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |