The following data is part of a premarket notification filed by Imaging Engineering, Llc with the FDA for Insight Agile Drf.
| Device ID | K210469 |
| 510k Number | K210469 |
| Device Name: | Insight Agile DRF |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Imaging Engineering, LLC 1318 NW 7th Ave Cape Coral, FL 33993 |
| Contact | George Jachode |
| Correspondent | George Jachode Imaging Engineering, LLC 1318 NW 7th Ave Cape Coral, FL 33993 |
| Product Code | JAA |
| Subsequent Product Code | OWB |
| Subsequent Product Code | OXO |
| Subsequent Product Code | QHY |
| Subsequent Product Code | RCC |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-07-27 |