The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. Ultrasound Gro with the FDA for Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound System.
| Device ID | K121646 |
| 510k Number | K121646 |
| Device Name: | ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-05 |
| Decision Date | 2012-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869053967 | K121646 | 000 |
| 04056869053950 | K121646 | 000 |
| 04056869053943 | K121646 | 000 |
| 04056869053936 | K121646 | 000 |
| 04056869004952 | K121646 | 000 |
| 04056869004389 | K121646 | 000 |
| 04056869004112 | K121646 | 000 |
| 04056869002811 | K121646 | 000 |