Imaging Engineering, LLC · Class II · Cleared Sep 16, 2025
| K-number | K251650 |
| Device name | Insight Enhanced DRF (EN-1002-01) |
| Applicant | Imaging Engineering, LLC |
| Product code | JAA |
| Device class | Class II |
| Decision date | Sep 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1650 |
The Insight Enhanced™ DRF (EN-1002-01) is an upgrade package that converts analog fluoroscopic imaging systems to digital by replacing the image intensifier and camera with a flat panel detector. It is intended for use by qualified physicians or technicians to obtain fluoroscopic and radiographic images of the skull, spinal column, chest, abdomen, and extremities in adult and pediatric patients.
The subject device uses a 17" x 17" dynamic flat panel detector compared to the predicate's 12-inch image intensifier, and includes medical-grade flat-panel monitors. The main components—computer, detector, and Insight DRF software—are identical to the predicate device. The predicate and subject device differ only in interface hardware to add compatibility with GE OEC 9800/9900 C-arms, while the x-ray generator and x-ray tube remain unmodified.
Not stated in this summary.
Bench testing on the OEC 9800 reference system demonstrated that the subject device produced substantially equivalent imaging and dose utilization characteristics across all magnification modes, pulsed fluoroscopy, continuous fluoroscopy, high-level fluoroscopy, CINE, and single spot image acquisition modes. Phantom testing using contrast detail phantoms, anatomic pelvis phantoms, and line-pair penetrometers showed equivalent image quality and dose performance to both the predicate device and the reference system, with no new safety or effectiveness concerns identified.
View the full FDA submission: accessdata.fda.gov