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.
| Device ID | K193257 |
| 510k Number | K193257 |
| Device Name: | ACUSON Sequoia Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions USA, Inc 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Sulgue Choi |
| Correspondent | Sulgue Choi Siemens Medical Solutions USA, Inc 685 East Middlefield Road Mountain View, CA 94043 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-01-31 |
| Summary: | summary |