K111416 is an FDA 510(k) clearance for the FALCON. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Viasonix , Ltd. (Yonkers, US). The FDA issued a Cleared decision on July 15, 2011, 56 days after receiving the submission on May 20, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K111416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2011 |
| Decision Date | July 15, 2011 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JOP — Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |