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.
| Device ID | K090276 |
| 510k Number | K090276 |
| Device Name: | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY 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 | DQO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-04 |
| Decision Date | 2009-02-19 |
| Summary: | summary |