The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Sonoline G20 Diagnostic Ultrasound Systems.
| Device ID | K071314 |
| 510k Number | K071314 |
| Device Name: | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY Mountain View, CA 94043 |
| Contact | Martina Vogt |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-10 |
| Decision Date | 2007-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869004617 | K071314 | 000 |
| 04056869003863 | K071314 | 000 |
| 04056869003917 | K071314 | 000 |
| 04056869003979 | K071314 | 000 |
| 04056869003986 | K071314 | 000 |
| 04056869003993 | K071314 | 000 |
| 04056869004402 | K071314 | 000 |
| 04056869004433 | K071314 | 000 |
| 04056869004440 | K071314 | 000 |
| 04056869004570 | K071314 | 000 |
| 04056869004594 | K071314 | 000 |
| 04056869003740 | K071314 | 000 |