The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc., Ultrasound Di with the FDA for Acuson Antares Diagnostic Ultrasound System.
| Device ID | K063803 |
| 510k Number | K063803 |
| Device Name: | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI 1230 SHOREBIRD WAY P O BOX 7393 Mountain View, CA 94039 -7393 |
| Contact | Michaela Mahl |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | 2006-12-22 |
| Decision Date | 2007-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869053929 | K063803 | 000 |
| 04056869003627 | K063803 | 000 |
| 04056869003610 | K063803 | 000 |
| 04056869003580 | K063803 | 000 |
| 04056869003566 | K063803 | 000 |
| 04056869003535 | K063803 | 000 |
| 04056869003481 | K063803 | 000 |
| 04056869003450 | K063803 | 000 |
| 04056869003399 | K063803 | 000 |
| 04056869003283 | K063803 | 000 |
| 04056869003252 | K063803 | 000 |
| 04056869003924 | K063803 | 000 |
| 04056869003931 | K063803 | 000 |
| 04056869027258 | K063803 | 000 |
| 04056869027203 | K063803 | 000 |
| 04056869027197 | K063803 | 000 |
| 04056869005003 | K063803 | 000 |
| 04056869004990 | K063803 | 000 |
| 04056869004945 | K063803 | 000 |
| 04056869004204 | K063803 | 000 |
| 04056869004198 | K063803 | 000 |
| 04056869004181 | K063803 | 000 |
| 04056869003948 | K063803 | 000 |
| 04056869003238 | K063803 | 000 |