K010187 is an FDA 510(k) clearance for the KIMAX, MODEL 1024. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Medical Metrics, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on February 14, 2001, 23 days after receiving the submission on January 22, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K010187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2001 |
| Decision Date | February 14, 2001 |
| Days to Decision | 23 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | JAA - System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |