The following data is part of a premarket notification filed by Acoustic Imaging Technologies Corp. with the FDA for Ai 5200 Diagnostic Ultrasound System.
| Device ID | K923273 |
| 510k Number | K923273 |
| Device Name: | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACOUSTIC IMAGING TECHNOLOGIES CORP. 10027 SOUTH 15ST ST. Phoenix, AZ 85044 |
| Contact | Lori Cadwell |
| Correspondent | Lori Cadwell ACOUSTIC IMAGING TECHNOLOGIES CORP. 10027 SOUTH 15ST ST. Phoenix, AZ 85044 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1994-12-27 |