The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson S1000/ S2000/ S3000 Diagnostic Ultrasound Systems.
| Device ID | K142876 |
| 510k Number | K142876 |
| Device Name: | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain, 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 | 2014-10-01 |
| Decision Date | 2014-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005492 | K142876 | 000 |
| 04056869003818 | K142876 | 000 |
| 04056869003801 | K142876 | 000 |
| 04056869003795 | K142876 | 000 |
| 04056869003139 | K142876 | 000 |
| 04056869003085 | K142876 | 000 |
| 04056869003023 | K142876 | 000 |
| 04056869002903 | K142876 | 000 |
| 04056869002897 | K142876 | 000 |
| 04056869003825 | K142876 | 000 |
| 04056869004044 | K142876 | 000 |
| 04056869005485 | K142876 | 000 |
| 04056869005478 | K142876 | 000 |
| 04056869005454 | K142876 | 000 |
| 04056869005027 | K142876 | 000 |
| 04056869004549 | K142876 | 000 |
| 04056869004150 | K142876 | 000 |
| 04056869004136 | K142876 | 000 |
| 04056869004051 | K142876 | 000 |
| 04056869002774 | K142876 | 000 |