K090334 is an FDA 510(k) clearance for the ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Siemens Medi Cal Solutions, Inc. (Mountainview, US). The FDA issued a Cleared decision on February 20, 2009, 10 days after receiving the submission on February 10, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K090334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2009 |
| Decision Date | February 20, 2009 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN - System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |