The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Modification To Acuson Antares Ultrasound System.
| Device ID | K063138 |
| 510k Number | K063138 |
| Device Name: | MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View, CA 94039 -7393 |
| Contact | Sheila W Pickering Ph.d. |
| Correspondent | Sheila W Pickering Ph.d. SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View, CA 94039 -7393 |
| 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 | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2006-11-22 |
| Summary: | summary |