K242662 is an FDA 510(k) clearance for the Falcon/Xpress (Falcon/Xpress). This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Viasonix , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on December 18, 2024, 105 days after receiving the submission on September 4, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K242662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2024 |
| Decision Date | December 18, 2024 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOP - Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |