The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Digital Flurographic Imaging System.
| Device ID | K813217 |
| 510k Number | K813217 |
| Device Name: | DIGITAL FLUROGRAPHIC IMAGING SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | DIASONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-09 |
| Decision Date | 1981-12-29 |