The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson Sc2000 Diagnostic Ultrasound System.
| Device ID | K211726 |
| 510k Number | K211726 |
| Device Name: | Acuson SC2000 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | OBJ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-04 |
| Decision Date | 2021-11-05 |