K241979 is an FDA 510(k) clearance for the Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro). This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Beijing Konted Medical Technology Co.,Ltd (Beijing, CN). The FDA issued a Cleared decision on August 22, 2024, 48 days after receiving the submission on July 5, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K241979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2024 |
| Decision Date | August 22, 2024 |
| Days to Decision | 48 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 |