K222365 is an FDA 510(k) clearance for the Leltek Ultrasound Imaging System (Model: LU700 Series). This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Leltek, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on October 25, 2022, 82 days after receiving the submission on August 4, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K222365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2022 |
| Decision Date | October 25, 2022 |
| Days to Decision | 82 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 |