The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc., Ultrasound Division with the FDA for Acuson Nx3 Elite / Nx3 Diagnostic Ultrasound System.
| Device ID | K152469 |
| 510k Number | K152469 |
| Device Name: | ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION 685 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 |
| Contact | Shelly Pearce |
| Correspondent | Mark Job 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 | 2015-08-31 |
| Decision Date | 2015-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005614 | K152469 | 000 |
| 04056869002941 | K152469 | 000 |
| 04056869003009 | K152469 | 000 |
| 04056869003245 | K152469 | 000 |
| 04056869003412 | K152469 | 000 |
| 04056869003542 | K152469 | 000 |
| 04056869004297 | K152469 | 000 |
| 04056869004303 | K152469 | 000 |
| 04056869005607 | K152469 | 000 |
| 04056869002880 | K152469 | 000 |