The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson X800 Diagnostic Ultrasound System.
| Device ID | K180067 |
| 510k Number | K180067 |
| Device Name: | ACUSON X800 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 |
| Contact | Sulgue Choi |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-01-09 |
| Decision Date | 2018-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869173566 | K180067 | 000 |
| 04056869284576 | K180067 | 000 |
| 04056869051970 | K180067 | 000 |
| 04056869051987 | K180067 | 000 |
| 04056869051994 | K180067 | 000 |
| 04056869052014 | K180067 | 000 |
| 04056869052021 | K180067 | 000 |
| 04056869052045 | K180067 | 000 |
| 04056869052069 | K180067 | 000 |
| 04056869061870 | K180067 | 000 |
| 04056869062013 | K180067 | 000 |
| 04056869284569 | K180067 | 000 |