K082798 is an FDA 510(k) clearance for the DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Medicatech USA (Deer Field, US). The FDA issued a Cleared decision on October 28, 2008, 35 days after receiving the submission on September 23, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K082798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2008 |
| Decision Date | October 28, 2008 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |