The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acuson Cypress Ultrasound System.
| Device ID | K052331 |
| 510k Number | K052331 |
| Device Name: | ACUSON CYPRESS 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 | Iskra Mrakovic |
| Correspondent | Iskra Mrakovic 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-26 |
| Decision Date | 2005-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005270 | K052331 | 000 |
| 04056869005263 | K052331 | 000 |
| 04056869003115 | K052331 | 000 |
| 04056869002996 | K052331 | 000 |
| 04056869002965 | K052331 | 000 |