The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson X700 Ultrasound System, Acuson X600 Ultrasound System.
| Device ID | K141846 |
| 510k Number | K141846 |
| Device Name: | ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 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 |
| Subsequent Product Code | OBJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-07-09 |
| Decision Date | 2014-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005584 | K141846 | 000 |
| 04056869002842 | K141846 | 000 |
| 04056869002859 | K141846 | 000 |
| 04056869003030 | K141846 | 000 |
| 04056869003504 | K141846 | 000 |
| 04056869003559 | K141846 | 000 |
| 04056869003603 | K141846 | 000 |
| 04056869003634 | K141846 | 000 |
| 04056869003757 | K141846 | 000 |
| 04056869003764 | K141846 | 000 |
| 04056869003771 | K141846 | 000 |
| 04056869004020 | K141846 | 000 |
| 04056869004129 | K141846 | 000 |
| 04056869005508 | K141846 | 000 |
| 04056869005546 | K141846 | 000 |
| 04056869005553 | K141846 | 000 |
| 04056869005560 | K141846 | 000 |
| 04056869005577 | K141846 | 000 |
| 04056869002804 | K141846 | 000 |