The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System.
| Device ID | K121699 |
| 510k Number | K121699 |
| Device Name: | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Shelly Pearce |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | DQO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-08 |
| Decision Date | 2012-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869027241 | K121699 | 000 |
| 04056869004105 | K121699 | 000 |
| 04056869004099 | K121699 | 000 |
| 04056869004082 | K121699 | 000 |
| 04056869004075 | K121699 | 000 |
| 04056869004068 | K121699 | 000 |
| 04056869004037 | K121699 | 000 |
| 04056869004006 | K121699 | 000 |
| 04056869003900 | K121699 | 000 |
| 04056869003849 | K121699 | 000 |
| 04056869003832 | K121699 | 000 |
| 04056869003597 | K121699 | 000 |
| 04056869003573 | K121699 | 000 |
| 04056869003405 | K121699 | 000 |
| 04056869003306 | K121699 | 000 |
| 04056869003290 | K121699 | 000 |
| 04056869002835 | K121699 | 000 |
| 04056869004143 | K121699 | 000 |
| 04056869004457 | K121699 | 000 |
| 04056869006017 | K121699 | 000 |
| 04056869005461 | K121699 | 000 |
| 04056869005447 | K121699 | 000 |
| 04056869005430 | K121699 | 000 |
| 04056869005416 | K121699 | 000 |
| 04056869005409 | K121699 | 000 |
| 04056869005393 | K121699 | 000 |
| 04056869005386 | K121699 | 000 |
| 04056869005362 | K121699 | 000 |
| 04056869005355 | K121699 | 000 |
| 04056869005348 | K121699 | 000 |
| 04056869005331 | K121699 | 000 |
| 04056869005324 | K121699 | 000 |
| 04056869005317 | K121699 | 000 |
| 04056869005300 | K121699 | 000 |
| 04056869004464 | K121699 | 000 |
| 04056869002828 | K121699 | 000 |