K202683 is an FDA 510(k) clearance for the ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on October 15, 2020, 30 days after receiving the submission on September 15, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K202683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2020 |
| Decision Date | October 15, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |