The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Ultrasound Scanner 501.
| Device ID | K834284 |
| 510k Number | K834284 |
| Device Name: | ULTRASOUND SCANNER 501 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1984-05-09 |