The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc. with the FDA for Acuson Nx3 Diagnostic Ultrasound System / Acuson Nx3 Elite Diagnostic Ultrasound System.
| Device ID | K192835 |
| 510k Number | K192835 |
| Device Name: | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions, USA, Inc. 22010 South East 51st Street Issaquah, WA 98029 |
| Contact | Hyunjung Lee |
| 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 |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-10-02 |
| Decision Date | 2019-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869284545 | K192835 | 000 |