K210432 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 November 3, 2021, 264 days after receiving the submission on February 12, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K210432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2021 |
| Decision Date | November 03, 2021 |
| Days to Decision | 264 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 |