The following data is part of a premarket notification filed by Acoustic Imaging Technologies Corp. with the FDA for Ai5200 Diag Ultra Sound Syst Includ 7.5 & 10.0 Mhz.
| Device ID | K924458 |
| 510k Number | K924458 |
| Device Name: | AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACOUSTIC IMAGING TECHNOLOGIES CORP. 10027 SOUTH 15ST ST. Phoenix, AZ 85044 |
| Contact | Michael A Parsons |
| Correspondent | Michael A Parsons 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 | 1992-09-02 |
| Decision Date | 1993-01-21 |