K140126 is an FDA 510(k) clearance for the SONIC WINDOW. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Analogic Corporation (Peabody, US). The FDA issued a Cleared decision on March 4, 2014, 47 days after receiving the submission on January 16, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K140126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2014 |
| Decision Date | March 04, 2014 |
| Days to Decision | 47 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |