The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Ada-1000 (advanced Digital Array).
| Device ID | K863780 |
| 510k Number | K863780 |
| Device Name: | ADA-1000 (ADVANCED DIGITAL ARRAY) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Contact | Fernandez, Jr. |
| Correspondent | Fernandez, Jr. DIASONICS, INC. 1565 BARBER LN. Milipitas, CA 95035 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-26 |
| Decision Date | 1986-12-29 |