The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc. Ultrasound Group with the FDA for Acuson S1000, S2000, S3000 Diagnostic Ultrasuond System.
| Device ID | K152369 |
| 510k Number | K152369 |
| Device Name: | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Nancy Burke |
| 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 |
| Subsequent Product Code | OBJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-08-21 |
| Decision Date | 2015-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869003177 | K152369 | 000 |
| 04056869002873 | K152369 | 000 |
| 04056869002798 | K152369 | 000 |
| 04056869002781 | K152369 | 000 |
| 04056869002750 | K152369 | 000 |