The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Omnia X/xs Ultrasound System.
| Device ID | K020353 |
| 510k Number | K020353 |
| Device Name: | OMNIA X/XS ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 22010 SE 51ST ST. Issaquah, WA 98029 |
| Contact | Judi Hoffman |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| 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 | 2002-02-04 |
| Decision Date | 2002-02-13 |
| Summary: | summary |