The following data is part of a premarket notification filed by Phoenix Radiology, Ltd. with the FDA for Fluoroscopic Image Intensifier.
| Device ID | K840621 |
| 510k Number | K840621 |
| Device Name: | FLUOROSCOPIC IMAGE INTENSIFIER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | PHOENIX RADIOLOGY, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-14 |
| Decision Date | 1984-06-05 |