The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Ra-i.
| Device ID | K781642 |
| 510k Number | K781642 |
| Device Name: | RA-I |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | DIASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-21 |
| Decision Date | 1978-10-10 |