The following data is part of a premarket notification filed by Phoenix Imaging with the FDA for Ai 5200 Diagnostic Ultrasound System.
| Device ID | K880839 |
| 510k Number | K880839 |
| Device Name: | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PHOENIX IMAGING 4666 SOUTH ASH AVE. Tempe, AZ 85282 |
| Contact | Matt Hedlund |
| Correspondent | Matt Hedlund PHOENIX IMAGING 4666 SOUTH ASH AVE. Tempe, AZ 85282 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-06-10 |