The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Acuson Sc2000 Diagnostic Ultrasound System.
| Device ID | K130754 |
| 510k Number | K130754 |
| Device Name: | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 685 EAST MIDDLEFIELD RD. Mountain View, CA 94043 |
| Contact | Patrick Lynch |
| 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 |
| Subsequent Product Code | OBJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-03-19 |
| Decision Date | 2013-03-25 |
| Summary: | summary |