The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Sonoline Antares Diagnostic Ultrasound System.
| Device ID | K050034 |
| 510k Number | K050034 |
| Device Name: | SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 22010 S.E. 51ST ST. Issaquah, WA 98029 |
| Contact | Patrick Lynch |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2005-01-07 |
| Decision Date | 2005-01-13 |
| Summary: | summary |