K172056 is an FDA 510(k) clearance for the InnoSight Diagnostic Ultrasound System. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Qisda Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on December 13, 2017, 160 days after receiving the submission on July 6, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K172056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2017 |
| Decision Date | December 13, 2017 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| 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 |