The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc. with the FDA for Acuson Sequoia Diagnostic Ultrasound System, Acuson Sc2000 Diagnostic Ultrasound System, Acuson Freestyle Diagnostic Ultrasound System,acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems, Acuson P200 Diagnostic Ultrasound System, Acuson P500 Dia.
| Device ID | K202683 |
| 510k Number | K202683 |
| Device Name: | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Dia |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions, USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029 |
| Contact | Christine Dunbar |
| Correspondent | Christine Dunbar Siemens Medical Solutions, USA, Inc. 22010 South East 51st Street Issaquah, WA 98029 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | OBJ |
| Subsequent Product Code | OIJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2020-10-15 |