The following data is part of a premarket notification filed by Alliance Medical, Inc. with the FDA for Amib7.
| Device ID | K990198 |
| 510k Number | K990198 |
| Device Name: | AMIB7 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ALLIANCE MEDICAL, INC. 7800 COTE DE LIESSE St. Laurent, Quebec, CA H4t 1g1 |
| Contact | James Riedl |
| Correspondent | James Riedl ALLIANCE MEDICAL, INC. 7800 COTE DE LIESSE St. Laurent, Quebec, CA H4t 1g1 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-06-29 |
| Summary: | summary |