The following data is part of a premarket notification filed by U-systems, Inc. with the FDA for U-systems Diagnostic Ultrasound System Usi-2000.
| Device ID | K013902 |
| 510k Number | K013902 |
| Device Name: | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | U-SYSTEMS, INC. 2081 LONGDEN CIRCLE Los Altos,, CA 94204 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering U-SYSTEMS, INC. 2081 LONGDEN CIRCLE Los Altos,, CA 94204 |
| 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 | 2001-11-26 |
| Decision Date | 2002-06-05 |
| Summary: | summary |