K233579 is an FDA 510(k) clearance for the SC1 Handheld Ultrasound Imaging system (Model: SC1). This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Fcu Co., Ltd. (Yuseong-Gu, KR). The FDA issued a Cleared decision on June 26, 2024, 232 days after receiving the submission on November 7, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K233579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2023 |
| Decision Date | June 26, 2024 |
| Days to Decision | 232 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |