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 | K221500 |
| 510k Number | K221500 |
| Device Name: | ACUSON Sequoia Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions USA, Inc 22010 South East 51st Street Issaquah, WA 98029 |
| Contact | Sulgue Choi |
| Correspondent | Prithul Bom 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 | OIJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-05-23 |
| Decision Date | 2022-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869287669 | K221500 | 000 |
| 04056869266275 | K221500 | 000 |
| 04056869266268 | K221500 | 000 |