The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Omniview Diagnostic Ultrasound System.
| Device ID | K954022 |
| 510k Number | K954022 |
| Device Name: | ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Paul D Smolenski |
| Correspondent | Paul D Smolenski ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-28 |
| Decision Date | 1996-01-17 |