The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Model Ssd-4000 Diagnostic Ultrasound System W/optional Sonoreal 3d System Accessory.
| Device ID | K040719 |
| 510k Number | K040719 |
| Device Name: | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Richard J Cehovsky |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-03-19 |
| Decision Date | 2004-03-26 |
| Summary: | summary |