The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Bi-plane Digital Fluorography Dfx7000.
| Device ID | K834286 |
| 510k Number | K834286 |
| Device Name: | BI-PLANE DIGITAL FLUOROGRAPHY DFX7000 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | ADAC LABORATORIES 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 | 1983-11-25 |
| Decision Date | 1984-01-04 |