K243620 is an FDA 510(k) clearance for the Vivid iq. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on February 11, 2025, 81 days after receiving the submission on November 22, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K243620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2024 |
| Decision Date | February 11, 2025 |
| Days to Decision | 81 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 |