K241554 is an FDA 510(k) clearance for the Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L). This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Telefield Medical Imaging (Shenzhen) Limited (Shenzhen, CN). The FDA issued a Cleared decision on October 24, 2024, 146 days after receiving the submission on May 31, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K241554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2024 |
| Decision Date | October 24, 2024 |
| Days to Decision | 146 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 |