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 Ultrasound Systems.
| Device ID | K163635 |
| 510k Number | K163635 |
| Device Name: | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions USA, Inc. Ultrasound Group 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Sulgue Choi |
| 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 | 2016-12-22 |
| Decision Date | 2017-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869284538 | K163635 | 000 |