The following data is part of a premarket notification filed by Siemens Healthcare with the FDA for Acuson S3000 S2000 S1000 Diagnostic Ultrasound Systems.
| Device ID | K172162 |
| 510k Number | K172162 |
| Device Name: | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Healthcare 22010 SE 51st St Issaquah, WA 98029 |
| Contact | Jessica Stenberg |
| 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 | 2017-07-18 |
| Decision Date | 2017-08-16 |
| Summary: | summary |