K981880 is an FDA 510(k) clearance for the DX-480, ADD ON DIGITAL IMAGER. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on October 20, 1998, 145 days after receiving the submission on May 28, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K981880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1998 |
| Decision Date | October 20, 1998 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |