K251650 is an FDA 510(k) clearance for the Insight Enhanced™ DRF (EN-1002-01). This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Imaging Engineering, LLC (Gainesville, US). The FDA issued a Cleared decision on September 16, 2025, 110 days after receiving the submission on May 29, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K251650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2025 |
| Decision Date | September 16, 2025 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA - System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |